EMA gave the green light to 89 medicines in 2022; including more ATMPs
Medicines given the go-ahead from the European regulator included gene therapy Breyanzi and monoclonal antibody Beyfortus: while smallpox vaccine Imvanex gained its indication for monkeypox.
New active substances
The number of recommendations for approval in 2022 was largely in line with previous years: following on from 92 medicines in 2021 and 97 in 2020.
Out of the 89 medicines in 2022 – which either went on to be officially authorized by the European Commission or have a final decision pending - 41 had a new active substance that had not previously been authorized in the European Union (EU).
Meanwhile, 90 extensions of indication were recommended, including 37 for pediatric use.
'Significant progress' in several therapeutic areas
Several of the 2022 recommendations represented ‘significant progress in their therapeutic areas’, noted the EMA.
The six advanced therapy medicinal products given the green light in 2022 represent an advance on the two authorized in 2021 (Skysona and Abecma) and three in 2020 (Zolgensma, Libmeldy, Tecartus).
Once the EMA issues a recommendation for authorization, the European Commission then officially authorizes the drug.
At this point, the medicine can be used in any of the Member States; although each country makes its own policy on how it is covered under its healthcare system.
Carvyki (ciltacabtagene autoleucel), a gene therapy for the treatment of relapsed and refractory multiple myeloma, was authorised in March.
Breyanzi, a gene therapy for the treatment of adults with three subtypes of non Hodgkin lymphoma (diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B)), became Bristol Myer Squibb’s second CAR-T cell therapy approved in the EU in April.
Upstaza has been authorized as a gene therapy in adults and children aged 18 months and older with severe aromatic L-amino acid decarboxylase (AADC) deficiency.
Roctavian has been authorized for the treatment of severe haemophilia A in adults who do not have factor VIII inhibitors; while CSL Behring's hemophilia B gene therapy Hemgenix was recommended for marketing authorization in December.
Meanwhile, Ebvallo was authorized at the end of the year for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease: intended for adults and children who develop this malignancy after receiving an organ or a bone marrow-transplantation.
EU first for Beyfortus
In September, the European Union became the first regulatory authority to approve AstraZeneca and Sanofi's monoclonal Beyfortus (nirsevimab) for the prevention of RSV lower respiratory tract disease in newborn babies and infants (a Biologics License Application has since been completed in the US alongside other regulatory submissions).
Eight biosimilars were recommended for approval in 2022 by the EMA: Vegzelma (referencing Avastin), Inpremzia (referencing Actrapid), Kauliv and Sondelbay (referencing Forsteo), insulin medicine Truvelog Mix 30 (referencing NovoMix 30), cancer drug Stimufend (referencing Neulasta), AMD and macular oedema drug Ximluci (referencing ranibizumab) and Ranivisio (referencing Lucentis).
The EMA says public health emergencies remained a key priority for EMA in 2022.
In response to the mpox outbreak (declared as a public health emergency of international concern by the WHO in July): the EMA recommended an extension of Bavarian Nordic's smallpox Imvanex vaccine to include mpox. The EMA’s Emergency Task Force also recommended that Jynneos, the vaccine in the US, can be used to prevent mpox in the EU while supplies remain low – meaning national authorities may decide to import Jynneos as a temporary measure.
COVID-19 also remained top-of-mind: with seven vaccines now authorized in the EU. Throughout 2022, the EMA continued to approve additional manufacturing capacity for COVID-19 vaccines, from 52 manufacturing sites approved in 2021 to 68 manufacturing sites in 2022.
"EMA is contributing to tackling the COVID-19 and mpox pandemics by expediting the development and approval of safe and effective treatments and vaccines," said the agency.
"This includes the reduction of timelines for evaluation to less than 150 working days and the use of rolling reviews."
The full summary of 2022 recommendations can be found here.