Fewer New Drugs than in 2022

Of the drugs recommended for authorization by the EMA’s Committee for Medical Products for Human Use (CHMP) in 2023, there were 39 new active substances, behind the FDA, with its record number of nods last year, and the EMA’s approvals of new drugs the previous year, which numbered 41 out of its total that year of 89.

The EMA signed off on 17 orphan drugs – three less than in the previous year -, 8 biosimilars, 15 generics, and 3 drugs that were recommended under the agency’s accelerated assessment pathway.

 

Cancer at the Top of the List

Cancer therapies led in the numbers of EMA nods in 2023 with 25 approvals. Among the cancer drugs that got the go-ahead last year, in its review of the year, the agency identified a handful of therapies that it considers significant breakthroughs.

Among these therapies are treatments for rare cancers such as Roche’s Columvi and Genmab and AbbVie’s Tepkinly for the treatment of diffuse large B-cell lymphoma, and Pfizer’s Elrexfio for relapsed or refractory multiple myeloma.

Talvay from Johnson & Johnson, which is for the treatment of adult patients with relapsed and refractory multiple myeloma, was also among the three medicines that received recommendations after an accelerated assessment, the EMA’s mechanism for medicines that address unmet medical needs.

 

Vaccines: COVID-19 and Lower Respiratory Tract Disease

The EMA endorsed four vaccines in 2023, including a new COVID-19 vaccine, Hipra’s Bimervax, evaluated as part of the OPEN initiative that began in December 2020 to increase international collaboration in the EU review of COVID-19 medicines, and three approved vaccines adapted to the Omicron XBB.1.5 variant.

For lower respiratory tract disease caused by respiratory syncytial virus (RSV), the agency gave its OK to two vaccines, Abrysvo from Pfizer and Arexvy from GSK.

Other noteworthy approvals include the first advanced therapy using the gene-editing technology known as CRISPR/Cas9 to treat two rare blood disorders.

 

Rejections

Red lights from the EMA last year were for Amylyx’s ALS drug Albrioza, which has already garnered the go-ahead from the FDA and has been shot down by the EMA twice; Merck’s COVID pill Lagevrio, and Ipsen’s rare bone disease fibrodysplasia ossificans progressive (FOP) treatment Sohonos.

 

Full List of Approvals:

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