Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
NewsHumanCOVID-19Medicines
EMA’s human medicines committee (CHMP) recommended thirteen medicines for approval at its February 2022 meeting.
The CHMP gave a positive opinion for Kimmtrak* (tebentafusp) for the treatment of uveal melanoma, a type of eye cancer. Kimmtrak was reviewed under EMA’s accelerated assessment programme. See more details in the news announcement in the grid below.
PreHevbri(Hepatitis B vaccine (recombinant, adsorbed)) was granted a positive opinion for the active immunisation against hepatitis B virus infection.
A positive opinion was adopted for Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease.
Orgovyx (relugolix) received a positive opinion from the CHMP for the treatment of prostate cancer.
The Committee gave a positive opinion for Quviviq (daridorexant) for the treatment of insomnia.
A positive opinion was adopted for Vydura (rimegepant) for the prophylaxis and acute treatment of migraine.
Two biosimilar medicines were recommended for approval: Inpremzia (insulin human (rDNA)) and Truvelog Mix 30 (insulin aspart), both for the treatment of diabetes mellitus.
Five generic medicines received a positive opinion from the Committee: Dimethyl fumarate Mylan (dimethyl fumarate), Dimethyl fumarate Neuraxpharm (dimethyl fumarate) and Dimethyl fumarate Polpharma (dimethyl fumarate), all for the treatment of adult patients with relapsing remitting multiple sclerosis; Amversio (betaine anhydrous) for the treatment of homocystinuria; and Sitagliptin Accord (sitagliptin) for the treatment of type 2 diabetes mellitus.
Recommendations on extensions of therapeutic indication for seven medicines
The Committee recommended a total of nine extensions of indication for medicines that are already authorised in the European Union (EU). These include Beovu, Delstrigo, Pifeltro, Verzenios and Yervoy, as well as Opdivo, for which the CHMP adopted three therapeutic extensions. It also includes an extension of the use of the COVID-19 vaccine Spikevax to children from 6-11 years of age. More information on this extension is available below and in a separate news announcement.
Re-examinations
Following a re-examination, the CHMP confirmed its original recommendation to refuse the granting of a marketing authorisation for Ipique (bevacizumab). This medicine was intended to treat neovascular (wet) age-related macular degeneration. For more information on this re-examination opinion, see the question-and-answer document in the grid below.
The applicant for Aduhelm (aducanumab), intended for the treatment of Alzheimer’s disease, requested a re-examination of the Committee’s December 2021 opinion not to grant a marketing authorisation.
The marketing authorisation holder for Tecfidera (dimethyl fumarate) requested a re-examination of EMA’s January 2022 opinion.
The re-examination procedures for both medicines will start upon receipt of the grounds for the requests, at the end of which the Agency will issue a final recommendation.
Readopted opinion
The Committee adopted a revised opinion for Padcev (enfortumab vedotin) after further safety information emerged during the decision-making process. Following a request from the European Commission, the CHMP readopted its opinion, taking into account the latest information.
COVID-19 updates
The CHMP recommended that a booster dose of the COVID-19 vaccine Comirnaty (tozinameran) may be given, where appropriate, to adolescents from 12 years of age. More details are available in a separate news announcement.
The Committee recommended granting an extension of indication for Spikevax (COVID-19 mRNA vaccine (nucleoside-modified)) to include the use of this COVID-19 vaccine in children aged 6 to 11. More details are available in a separate news announcement.
The CHMP also recommended including the use of Spikevax as a booster dose in people who have previously completed a primary vaccination with another mRNA vaccine or an adenoviral vector vaccine.
An increase in manufacturing capacity for COVID-19 vaccine Spikevax was approved by the CHMP.
Agenda and minutes
The agenda of the February 2022 CHMP meeting is published on EMA's website. Minutes of the January 2022 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the February 2022 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
Positive recommendations on new medicines
| Name of medicine | Kapruvia |
| International non-proprietary name (INN) | difelikefalin |
| Marketing-authorisation applicant | Vifor Fresenius Medical Care Renal Pharma France |
| Therapeutic indication | Treatment of moderate-to-severe pruritus associated with chronic kidney disease |
| More information | Kapruvia: Pending EC decision |
| Name of medicine | Kimmtrak |
| INN | tebentafusp |
| Marketing-authorisation applicant | Immunocore Ireland Limited |
| Therapeutic indication | Treatment of uveal melanoma |
| More information | News announcement:New medicine for rare type of eye cancer |
| Name of medicine | Orgovyx |
| INN | relugolix |
| Marketing-authorisation applicant | Myovant Sciences Ireland Limited |
| Therapeutic indication | Treatment of prostate cancer |
| More information | Orgovyx: Pending EC decision |
| Name of medicine | PreHevbri |
| Common name | Hepatitis B vaccine (recombinant, adsorbed) |
| Marketing-authorisation applicant | VBI Vaccines B.V. |
| Therapeutic indication | Active immunisation against hepatitis B virus infection |
| More information | PreHevbri: Pending EC decision |
| Name of medicine | Quviviq |
| INN | daridorexant |
| Marketing-authorisation applicant | Idorsia Pharmaceuticals Deutschland GmbH |
| Therapeutic indication | Treatment of insomnia |
| More information | Quviviq: Pending EC decision |
| Name of medicine | Vydura |
| INN | rimegepant |
| Marketing-authorisation applicant | Biohaven Pharmaceutical Ireland DAC |
| Therapeutic indication | Prophylaxis and acute treatment of migraine |
| More information | Vydura: Pending EC decision |
Positive recommendations on new biosimilar medicines
| Name of medicine | Inpremzia |
| INN | insulin human (rDNA) |
| Marketing-authorisation applicant | Baxter Holding B.V. |
| Therapeutic indication | Treatment of diabetes mellitus |
| More information | Inpremzia: Pending EC decision |
| Name of medicine | Truvelog Mix 30 |
| INN | insulin aspart |
| Marketing-authorisation applicant | sanofi-aventis groupe |
| Therapeutic indication | Treatment of diabetes mellitus |
| More information | Truvelog Mix 30: Pending EC decision |
Positive recommendations on new generic medicines
| Name of medicine | Amversio |
| INN | betaine anhydrous |
| Marketing-authorisation applicant | SERB SA |
| Therapeutic indication | Treatment of homocystinuria |
| More information | Amversio: Pending EC decision |
| Name of medicine | Dimethyl fumarate Mylan |
| INN | dimethyl fumarate |
| Marketing-authorisation applicant | Mylan Ireland Limited |
| Therapeutic indication | Treatment of adult patients with relapsing remitting multiple sclerosis |
| More information | Dimethyl fumarate Mylan: Pending EC decision |
| Name of medicine | Dimethyl fumarate Neuraxpharm |
| INN | dimethyl fumarate |
| Marketing-authorisation applicant | Laboratorios Lesvi S.L. |
| Therapeutic indication | Treatment of adult patients with relapsing remitting multiple sclerosis |
| More information | Dimethyl fumarate Neuraxpharm: Pending EC decision |
| Name of medicine | Dimethyl fumarate Polpharma |
| INN | dimethyl fumarate |
| Marketing-authorisation applicant | Zak?ady Farmaceutyczne Polpharma S.A. |
| Therapeutic indication | Treatment of adult patients with relapsing remitting multiple sclerosis |
| More information | Dimethyl fumarate Polpharma: Pending EC decision |
| Name of medicine | Sitagliptin Accord |
| INN | sitagliptin |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of type 2 diabetes mellitus |
| More information | Sitagliptin Accord: Pending EC decision |
Re-examination of initial application following negative opinion
| Name of medicine | Aduhelm |
| INN | aducanumab |
| Marketing-authorisation applicant | Biogen Netherlands B.V. |
| Therapeutic indication | Treatment of Alzheimer’s disease |
| More information | Aduhelm: Questions and answers |
Positive recommendations on extensions of indications
| Name of medicine | Beovu |
| INN | brolucizumab |
| Marketing-authorisation holder | Novartis Europharm Limited |
| More information | Beovu: Pending EC decision |
| Name of medicine | Delstrigo |
| INN | doravirine / lamivudine / tenofovir disoproxil |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information | Delstrigo: Pending EC decision |
| Name of medicine | Opdivo |
| INN | nivolumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information | Opdivo: Pending EC decision |
| Name of medicine | Pifeltro |
| INN | doravirine |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information | Pifeltro: Pending EC decision |
| Name of medicine | Spikevax |
| INN | COVID-19 mRNA vaccine (nucleoside-modified) |
| Marketing-authorisation holder | Moderna Biotech Spain, S.L. |
| More information | Spikevax (previously COVID-19 Vaccine Moderna): Pending EC decision News announcement:EMA recommends approval of Spikevax for children aged 6 to 11 (24/02/2022) |
| Name of medicine | Verzenios |
| INN | abemaciclib |
| Marketing-authorisation holder | Eli Lilly Nederland B.V. |
| More information | Verzenios: Pending EC decision |
| Name of medicine | Yervoy |
| INN | ipilimumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information | Yervoy: Pending EC decision |
Readopted opinion
| Name of medicine | Padcev |
| INN | enfortumab vedotin |
| Marketing-authorisation applicant | Astellas Pharma Europe B.V. |
| Therapeutic indication | Treatment of locally advanced or metastatic urothelial cancer |
| More information | Padcev: Pending EC decision |
Re-examination of extension of indication
| Name of medicine | Tecfidera |
| INN | dimethyl fumarate |
| Marketing-authorisation holder | Biogen Netherlands B.V. |
| More information | Tecfidera: Pending EC decision |
Outcome of re-examination
| Name of medicine | Ipique |
| INN | bevacizumab |
| Marketing-authorisation holder | Rotterdam Biologics B.V. |
| More information | Ipique: Pending EC decision |