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 for the 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 / Metformin hydrochloride 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, Lacosamide UCB, 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.