Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
Sixteen medicines recommended for approval, including two orphans
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The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended 16 medicines for approval, including two orphan medicines1, at its July 2018 meeting.
The Committee recommended granting a marketing authorisation for Onpattro (patisiran), for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (a condition in which the peripheral nerves are damaged). This medicine was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest. Onpattro was designated as an orphan medicine during its development. For more information, please see the press release in the grid below.
The CHMP recommended granting two new paediatric-use marketing authorisations (PUMAs), for Kigabeq (vigabatrin), for the treatment of infantile spasms (West's syndrome) and resistant partial epilepsy, and Slenyto (melatonin), for the treatment of insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome. For more information, please see the press release in the grid below.
Symkevi (tezacaftor / ivacaftor) received a positive opinion for the treatment of cystic fibrosis. Symkevi was designated as an orphan medicine during its development.
The Committee adopted a positive opinion for Xerava (eravacycline), a new antibacterial medicine for the treatment of complicated intra-abdominal infections in adults.
The CHMP recommended granting marketing authorisations for four cancer medicines: Braftovi (encorafenib) and Mektovi (binimetinib), two medicines to be used in combination in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation; Imfinzi (durvalumab), for the treatment of non-small cell lung cancer and Verzenios (abemaciclib), for the treatment of locally advanced or metastatic breast cancer.
Ilumetri (tildrakizumab) received a positive opinion for the treatment of moderate to severe plaque psoriasis.
Three biosimilar medicines received a positive opinion from the Committee: Hulio (adalimumab), for the treatment of certain inflammatory and autoimmune disorders; Pelgraz (pegfilgrastim) and Udenyca (pegfilgrastim), both intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.
The CHMP recommended granting a marketing authorisation for three generic medicines: Deferiprone Lipomed (deferiprone), for the treatment of iron overload in patients with thalassaemia major; Gefitinib Mylan (gefitinib), for the treatment of non-small cell lung cancer and Lenalidomide Accord (lenalidomide), for the treatment of multiple myeloma.
Negative recommendations on new medicines following re-examination
The applicants for Dexxience (betrixaban) and Eladynos (abaloparatide) requested re-examinations of the Committee's negative opinions for these medicines adopted at the March 2018 meeting. After considering the grounds for these requests, the CHMP re-examined the initial opinions and confirmed its previous recommendations to refuse the granting of marketing authorisations for these medicines.
For more information on these negative opinions, please see the question-and-answer documents in the grid below.
Twelve recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Abseamed, Binocrit, Blincyto, Darzalex, Epoetin alfa Hexal, Kalydeco, Mekinist, Nucala, Tafinlar, Xarelto and two extensions of indication for Keytruda.
Negative opinions on extension of therapeutic indication
The CHMP adopted a negative opinion for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer).
The Committee also adopted a negative opinion for an extension of therapeutic indication for Blincyto in patients with minimal residual disease after treatment for B-precursor acute lymphoblastic leukaemia.
For more information on these negative opinions, please see the question-and-answer documents in the grid below.
Outcome of review on Xofigo
The CHMP recommended restricting the use of Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments. For more information, please see the public health recommendation in the grid below.
Withdrawals of applications
The application for an initial marketing authorisation for Raligize (axalimogene filolisbac) was withdrawn. This medicine was intended to be used for the treatment of cervical cancer.
Applications to extend the use of Opdivo (nivolumab) to the treatment of stomach cancer and Sutent (sunitinib) to treat patients at high risk of kidney cancer returning after surgery have also been withdrawn.
Question-and-answer documents on these withdrawals are available in the grid below.
Agenda and minutes
The agenda of the July 2018 meeting is published on EMA's website. Minutes of the June 2018 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the July 2018 CHMP meeting are represented in the graphic below.
1 As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines' orphan status and granting the medicines ten years of market exclusivity.
Positive recommendations on new medicines
| Name of medicine | Braftovi |
|---|---|
| INN | encorafenib |
| Marketing-authorisation applicant | Pierre Fabre Medicament |
| Therapeutic indication | In combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation |
| More information | CHMP summary of positive opinion for Braftovi |
| Name of medicine | Ilumetri |
|---|---|
| INN | tildrakizumab |
| Marketing-authorisation applicant | Almirall S.A. |
| Therapeutic indication | Treatment of moderate to severe plaque psoriasis |
| More information | CHMP summary of positive opinion for Ilumetri |
| Name of medicine | Imfinzi |
|---|---|
| INN | durvalumab |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Treatment of non-small cell lung cancer |
| More information | CHMP summary of positive opinion for Imfinzi |
| Name of medicine | Mektovi |
|---|---|
| INN | binimetinib |
| Marketing-authorisation applicant | Pierre Fabre Medicament |
| Therapeutic indication | In combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation |
| More information | CHMP summary of positive opinion for Mektovi |
| Name of medicine | Onpattro |
|---|---|
| INN | patisiran |
| Marketing-authorisation applicant | Alnylam Netherlands B.V. |
| Therapeutic indication | Treatment of hereditary transthyretin-mediated amyloidosis |
| More information | CHMP summary of positive opinion for Onpattro
Press release: New medicine for hereditary rare disease |
| Name of medicine | Slenyto |
|---|---|
| INN | melatonin |
| Marketing-authorisation applicant | RAD Neurim Pharmaceuticals EEC Ltd. |
| Therapeutic indication | Treatment of insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome |
| More information | CHMP summary of positive opinion for Slenyto
Press release: Two new paediatric-use marketing authorisations recommended by CHMP |
| Name of medicine | Symkevi |
|---|---|
| INN | tezacaftor / ivacaftor |
| Marketing-authorisation applicant | Vertex Pharmaceuticals (Europe) Ltd. |
| Therapeutic indication | Treatment of cystic fibrosis |
| More information | CHMP summary of positive opinion for Symkevi |
| Name of medicine | Verzenios |
|---|---|
| INN | abemaciclib |
| Marketing-authorisation applicant | Eli Lilly Nederland B.V. |
| Therapeutic indication | Treatment of locally advanced or metastatic breast cancer |
| More information | CHMP summary of positive opinion for Verzenios |
| Name of medicine | Xerava |
|---|---|
| INN | eravacycline |
| Marketing-authorisation applicant | Tetraphase Pharmaceuticals Ireland Limited |
| Therapeutic indication | Treatment of complicated intra-abdominal infections in adults |
| More information | CHMP summary of positive opinion for Xerava |
Positive recommendations on new generic medicines
| Name of medicine | Deferiprone Lipomed |
|---|---|
| INN | deferiprone |
| Marketing-authorisation applicant | Lipomed GmbH |
| Therapeutic indication | Treatment of iron overload in patients with thalassaemia major |
| More information | CHMP summary of positive opinion for Deferiprone Lipomed |
| Name of medicine | Gefitinib Mylan |
|---|---|
| International non-proprietary name (INN) | gefitinib |
| Marketing-authorisation applicant | Mylan S.A.S. |
| Therapeutic indication | Treatment of non-small cell lung cancer |
| More information | CHMP summary of positive opinion for Gefitinib Mylan |
| Name of medicine | Lenalidomide Accord |
|---|---|
| International non-proprietary name (INN) | lenalidomide |
| Marketing-authorisation applicant | Accord Healthcare Limited |
| Therapeutic indication | Treatment of multiple myeloma |
| More information | CHMP summary of positive opinion for Lenalidomide Accord |
Positive recommendations on new biosimilar medicines
| Name of medicine | Hulio |
|---|---|
| International non-proprietary name (INN) | adalimumab |
| Marketing-authorisation applicant | Mylan S.A.S |
| Therapeutic indication | Treatment of certain inflammatory and autoimmune disorders |
| More information | CHMP summary of positive opinion for Hulio |
| Name of medicine | Pelgraz |
|---|---|
| INN | pegfilgrastim |
| Marketing-authorisation applicant | Accord Healthcare Limited |
| Therapeutic indication | Intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy |
| More information | CHMP summary of positive opinion for Pelgraz |
| Name of medicine | Udenyca |
|---|---|
| INN | pegfilgrastim |
| Marketing-authorisation applicant | ERA Consulting GmbH |
| Therapeutic indication | Intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy |
| More information | CHMP summary of positive opinion for Udenyca |
Positive recommendations on new hybrid medicine
| Name of medicine | Kigabeq |
|---|---|
| INN | vigabatrin |
| Marketing-authorisation applicant | Orphelia Pharma SAS |
| Therapeutic indication | Treatment of infantile spasms (West's syndrome) and resistant partial epilepsy (focal onset seizures) in infants and children |
| More information | CHMP summary of positive opinion for Kigabeq
Press release: Two new paediatric-use marketing authorisations recommended by CHMP |
Negative recommendation for new medicines following re-examination
| Name of medicine | Dexxience |
|---|---|
| INN | betrixaban |
| Marketing-authorisation applicant | Portola Pharma UK Limited |
| Therapeutic indication | Prevention of venous thromboembolism |
| More information | Questions and answers on refusal of the marketing authorisation for Dexxience (betrixaban) |
| Name of medicine | Eladynos |
|---|---|
| INN | abaloparatide |
| Marketing-authorisation applicant | Radius International Ltd |
| Therapeutic indication | Treatment of osteoporosis |
| More information | Questions and answers on refusal of the marketing authorisation for Eladynos (abaloparatide) |
Positive recommendations on extensions of indications
| Name of medicine | Abseamed |
|---|---|
| INN | epoetin alfa |
| Marketing-authorisation holder | Medice Arzneimittel Pütter GmbH & Co. KG |
| More information | CHMP post-authorisation summary of positive opinion for Abseamed |
| Name of medicine | Binocrit |
|---|---|
| INN | epoetin alfa |
| Marketing-authorisation holder | Sandoz GmbH |
| More information | CHMP post-authorisation summary of positive opinion for Binocrit |
| Name of medicine | Blincyto |
|---|---|
| INN | blinatumomab |
| Marketing-authorisation holder | Amgen Europe B.V. |
| More information | CHMP post-authorisation summary of positive opinion for Blincyto (II-18) |
| Name of medicine | Darzalex |
|---|---|
| INN | daratumumab |
| Marketing-authorisation holder | Janssen-Cilag International NV |
| More information | CHMP post-authorisation summary of positive opinion for Darzalex (II-11) |
| Name of medicine | Epoetin alfa Hexal |
|---|---|
| INN | epoetin alfa |
| Marketing-authorisation holder | Hexal AG |
| More information | CHMP post-authorisation summary of positive opinion for Epoetin alfa Hexal |
| Name of medicine | Kalydeco |
|---|---|
| INN | ivacaftor |
| Marketing-authorisation holder | Vertex Pharmaceuticals (Europe) Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Kalydeco (II-63-G) |
| Name of medicine | Keytruda |
|---|---|
| INN | pembrolizumab |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information | CHMP post-authorisation summary of positive opinion for Keytruda (II-42;II-43) |
| Name of medicine | Mekinist |
|---|---|
| INN | trametinib |
| Marketing-authorisation holder | Novartis Europharm Limited |
| More information | CHMP post-authorisation summary of positive opinion for Mekinist (WS/1274) |
| Name of medicine | Nucala |
|---|---|
| INN | mepolizumab |
| Marketing-authorisation holder | GlaxoSmithKline Trading Services Limited |
| More information | CHMP post-authorisation summary of positive opinion for Nucala |
| Name of medicine | Tafinlar |
|---|---|
| INN | dabrafenib |
| Marketing-authorisation holder | Novartis Europharm Limited |
| More information | CHMP post-authorisation summary of positive opinion for Tafinlar (WS-1274) |
| Name of medicine | Xarelto |
|---|---|
| INN | rivaroxaban |
| Marketing-authorisation holder | Bayer AG |
| More information | CHMP post-authorisation summary of positive opinion for Xarelto (II-58) |
Recommendation for new contraindication
| Name of medicine | Viekirax |
|---|---|
| INN | ombitasvir / paritaprevir / ritonavir |
| Marketing-authorisation holder | AbbVie Deutschland GmbH & Co. KG |
| More information | CHMP post-authorisation summary of positive opinion for Viekirax (WS-1348) |
Negative recommendations on extensions of indications
| Name of medicine | Blincyto |
|---|---|
| INN | blinatumomab |
| Marketing-authorisation holder | Amgen Europe B.V. |
| More information | Questions and answers on the refusal of a change to the marketing authorisation for Blincyto |
| Name of medicine | Opdivo |
|---|---|
| INN | nivolumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information | Questions and answers on the refusal of a change to the marketing authorisations for Opdivo (nivolumab) and Yervoy (ipilimumab) |
| Name of medicine | Yervoy |
|---|---|
| INN | ipilimumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information | Questions and answers on the refusal of a change to the marketing authorisations for Opdivo (nivolumab) and Yervoy (ipilimumab) |
Public-health recommendation
| Name of medicine | Xofigo |
|---|---|
| INN | radium-223 dichloride |
| More information | EMA restricts use of prostate cancer medicine Xofigo |
Withdrawal of initial marketing authorisation application
| Name of medicine | Raligize |
|---|---|
| INN | axalimogene filolisbac |
| Marketing-authorisation applicant | FGK Representative Service GmbH |
| More information | Questions and answers on the withdrawal of the marketing authorisation application for Raligize (axalimogene filolisbac) |
Withdrawal of extension of indication applications
| Name of medicine | Opdivo |
|---|---|
| INN | nivolumab |
| Marketing-authorisation applicant | Bristol-Myers Squibb Pharma EEIG |
| More information | Questions and answers on the withdrawal of the marketing authorisation application for Opdivo (nivolumab) (II/0039) |
| Name of medicine | Sutent |
|---|---|
| INN | sunitinib |
| Marketing-authorisation applicant | Pfizer Limited |
| More information | Questions and answers on the withdrawal of application for a change to the marketing authorisation for Sutent (sunitinib) |