The CHMP is the European Medicines Agency’s (EMA) committee responsible for human medicines. It plays a key role in authorisation of medicines in the European Union. The CHMP meets once a month to exercise its duties. Click here to download CHMP’s meeting dates.
In its latest meeting, CHMP recommended seven new medicines for approval, including the antiviral Paxlovid (PF-07321332/ritonavir) for COVID-19 and Breyanzi (lisocabtagene maraleucel), a gene therapy for large B-cell lymphomas.
Approvals
PAXLOVID™ (Nirmatrelvir and Ritonavir) – Pfizer
The committee recommended granting conditional marketing authorisation to Paxlovid for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.
Paxlovid is the first oral antiviral recommended for treating COVID-19 in the EU and contains two active substances, Nirmatrelvir and ritonavir. Nirmatrelvir reduces the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body while ritonavir prolongs the action of Nirmatrelvir.
The decision was based on trial results in which Paxlovid significantly reduced hospitalisations or deaths in patients who have at least one underlying condition putting them at risk of severe COVID-19. Over the month following treatment, the rate of hospitalisation or death was 0.8 percent (8 out of 1,039) for Paxlovid recipients and 6.3 percent (66 out of 1,046) for placebo. There were no deaths with Paxlovid and 12 deaths in the placebo group.
BREYANZI® (Lisocabtagene maraleucel) – Bristosl Myers Squibb
BREYANZI® is an immune-cell-based gene therapy. A patient’s T cells are extracted and genetically engineered to express a chimeric antigen receptor (CAR) protein that allows them to target and eliminate cancer cells, before being reinfused in the patient.
Breyanzi had PRIME designation and benefited from early and enhanced dialogue between the EMA and its developers. A positive opinion was given to Breyanzi 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.
The CHMP based the decision on the safety of Breyanzi, examined in four studies involving over 300 treated patients, and the efficacy in two studies pooling about 350 patients. The efficacy trials concluded that clinical benefit would be expected with a meaningful disease control in a substantial proportion of patients.
Biosimilars and Generics
CHMP adopted a positive opinion, and recommended the granting of marketing authorisations for the following biosimilars/generics:
Sondelbay (Teriparatide) for the treat osteoporosis and Stimufend (Pegfilgrastim) for the reduction of the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy were the two biosimilars that received recommendations for approval.
Dasatinib Accord (Dasatinib) for the treatment of leukaemia, and Vildagliptin/Metformin hydrochloride for the treatment of type 2 diabetes. Dasatinib Accord is a generic of Sprycel, which has been authorised in the EU since 20 November 2006.
Indication Extensions
Eight medicines were recommended for indication extensions, namely Ayvakyt, Briviact, Dupixent, Jardiance, Lacosamide, Senshio, Tecfidera and Vimpat.
Miscellaneous Actions
Rotterdam Biologics B.V., the applicant for Ipique (Bevacizumab) requested a re-examination of the committee’s earlier opinion not to grant an authorisation.
CHMP completed a review of Nasolam (Midazolam, Nasal spray) and concluded 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.
CHMP concluded, following it’s review of Stresam (Etifoxine), 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.
