Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 2022
NewsHumanCOVID-19Medicines
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its January 2022 meeting.
The antiviral Paxlovid (PF-07321332 / ritonavir) received a positive opinion from the Committee for a conditional marketing authorisation for the treatment of COVID-19. More details are available in a separate news announcement.
The CHMP gave a positive opinion forthe new gene therapy Breyanzi* (lisocabtagene maraleucel) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two previous lines of treatment. Since Breyanzi addresses an unmet medical need, it benefitted from support within the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines. See more details in the news announcement in the grid below.
Two biosimilar medicines were recommended for approval: Sondelbay (teriparatide) to treat osteoporosis and Stimufend (pegfilgrastim) to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.
Three generic medicines received a positive opinion from the Committee: Dasatinib Accord (dasatinib) and Dasatinib Accordpharma (dasatinib) for the treatment of leukaemia, and Vildagliptin / Metforminhydrochloride Accord (vildagliptin / metformin hydrochloride) for the treatment of type 2 diabetes.
Recommendations on extensions of therapeutic indication for eight medicines
The Committee recommended extensions of indication for Ayvakyt, Briviact, Dupixent, Jardiance, LacosamideUCB, Senshio, Tecfidera and Vimpat.
Re-examination
The applicant for Ipique (bevacizumab) requested a re-examination of the Committee’s opinion not to grant an authorisation for this medicine adopted at its November 2021 meeting. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.
Start of referral
EMA has started a review of medicines for which studies have been conducted by Synchron Research Services, a contract research organisation (CRO) located in Ahmedabad, India. For more information, see the public health communication in the grid below.
Arbitration procedure: Re-examination stopped after withdrawal of application
The re-examination of the CHMP’s opinion on Lidocain / Prilocain Idetec and associated names (lidocaine/prilocaine cream) was stopped as the applicant decided to withdraw its application for marketing authorisation of these medicines in the concerned Member States.
For more information, see the updated Q&A document.
Outcome of arbitration procedure
The CHMP completed a review of Nasolam (midazolam, nasal spray), concluding that the benefits of this medicine outweigh its risks, and that marketing authorisations should be granted in those Member States of the EU where the company has applied.
For more information, see the Q&A document in the grid below.
Conclusion of referral
Finalising its review of Stresam (etifoxine), the CHMP concluded that the medicine can continue to be used for the treatment of anxiety disorders but must not be used in patients who previously had severe skin reactions or severe liver problems after taking etifoxine.
For more information, see the public health communication in the grid below.
Withdrawals of applications
Applications for a marketing authorisation for Abylqis (arachis hypogaea extract) and Aliqopa (copanlisib) were withdrawn. Abylqis was intended for the treatment of peanut allergies; Aliqopa was intended for treatment of adult patients with relapsed marginal zone lymphoma.
The marketing authorisation holders for Brilique (ticagrelor) and Tookad (padeliporfin) withdrew their applications to extend the use of these medicines. The application for Brilique concerned adding prevention of stroke in adults after a mild-to-moderate acute ischaemic stroke or high-risk transient ischaemic attack. The application for Tookad was to include the treatment of patients with a higher grade of prostate cancer, as per the International Society of Urological Pathology.
Question-and-answer documents on the withdrawals are available in the grid below.
Agenda and minutes
The agenda of the January 2022 CHMP meeting is published on EMA's website. Minutes of the December 2021 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the January 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 | Breyanzi |
| INN | lisocabtagene maraleucel |
| Marketing-authorisation applicant | Bristol-Myers Squibb Pharma EEIG |
| Therapeutic indication | Treatment of relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) |
| More information | News announcement:New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma |
| Name of medicine | Paxlovid |
| INN | PF-07321332 / ritonavir |
| Marketing-authorisation applicant | Pfizer Europe MA EEIG |
| Therapeutic indication | Treatment of COVID-19 |
| More information | News announcement:COVID-19: EMA recommends conditional marketing authorisation for Paxlovid |
Positive recommendations on new biosimilar medicines
| Name of medicine | Sondelbay |
| INN | teriparatide |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of osteoporosis |
| More information | Sondelbay: Pending EC decision |
| Name of medicine | Stimufend |
| INN | pegfilgrastim |
| Marketing-authorisation applicant | Fresenius Kabi Deutschland GmbH |
| Therapeutic indication | Reduction of the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy |
| More information | Stimufend: Pending EC decision |
Positive recommendations on new generic medicines
| Name of medicine | Dasatinib Accord |
| INN | dasatinib |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of leukaemia |
| More information | Dasatinib Accord: Pending EC decision |
| Name of medicine | Dasatinib Accordpharma |
| INN | dasatinib |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of leukaemia |
| More information | Dasatinib Accordpharma: Pending EC decision |
| Name of medicine | Vildagliptin / Metformin hydrochloride Accord |
| INN | vildagliptin / metformin hydrochloride |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of type 2 diabetes |
| More information | Vildagliptin / Metformin hydrochloride Accord Healthcare: Pending EC decision |
Re-examination of recommendation for new medicine
| Name of medicine | Ipique |
| INN | bevacizumab |
| Marketing-authorisation applicant | Rotterdam Biologics B.V. |
| Therapeutic indication | Treatment of neovascular (wet) age-related macular degeneration |
| More information | Ipique: Pending EC decision |
| Name of medicine | Abylqis |
| INN | arachis hypogaea extract |
| More information | Abylqis: Withdrawn application |
| Name of medicine | Aliqopa |
| INN | copanlisib |
| More information | Aliqopa: Withdrawn application |
| Name of medicine | Tookad |
| INN | padeliporfin |
| More information | Tookad: Withdrawn application |
| Name of medicine | Brilique |
| INN | ticagrelor |
| More information | Brilique: Withdrawn application |
Positive recommendations on new therapeutic indications
| Name of medicine | Ayvakyt |
| INN | avapritinib |
| Marketing-authorisation holder | Blueprint Medicines (Netherlands) B.V. |
| More information | Ayvakyt: Pending EC decision |
| Name of medicine | Briviact |
| INN | brivaracetam |
| Marketing-authorisation holder | UCB Pharma S.A. |
| More information | Briviact (in Italy: Nubriveo): Pending EC decision |
| Name of medicine | Dupixent |
| INN | dupilumab |
| Marketing-authorisation holder | sanofi-aventis groupe |
| More information | Dupixent: Pending EC decision |
| Name of medicine | Jardiance |
| INN | empagliflozin |
| Marketing-authorisation holder | Boehringer Ingelheim International GmbH |
| More information | Jardiance: Pending EC decision |
| Name of medicine | Lacosamide UCB |
| INN | lacosamide |
| Marketing-authorisation holder | UCB Pharma S.A. |
| More information | Lacosamide UCB: Pending EC decision |
| Name of medicine | Senshio |
| INN | ospemifene |
| Marketing-authorisation holder | Shionogi B.V. |
| More information | Senshio: Pending EC decision |
| Name of medicine | Tecfidera |
| INN | dimethyl fumarate |
| Marketing-authorisation holder | Biogen Netherlands B.V. |
| More information | Tecfidera: Pending EC decision |
| Name of medicine | Vimpat |
| INN | lacosamide |
| Marketing-authorisation holder | UCB Pharma S.A. |
| More information | Vimpat: Pending EC decision |
Conclusion of referral
| Name of medicine | Stresam |
| INN | etifoxine |
| More information | Etifoxine-containing medicinal products |
Start of referral
| Name of medicine | Synchron |
| INN | various |
| More information | Synchron |
Outcome of arbitration procedure
| Name of medicine | Nasolam |
| INN | midazolam |
| More information | Nasolam and associated names |