Increased approvals for new active substances in the EU in 2021

By Rachel Arthur contact

- Last updated on GMT

Pic:getty/porcorex
Pic:getty/porcorex

Related tags: European medicines agency, European union

The European Medicines Agency (EMA) recommended 92 medicines for marketing authorization in 2021: 54 of which had a new active substance which had never been authorized in the EU before.

This represents a 35% increase compared to the 39 medicines with a new active substance that were authorized in 2020.

New cancer treatments

Several authorizations in 2021 represented ‘significant progress’ in their therapeutic areas, observed the EMA as it published a review​ of the year’s recommendations.

Two cancer treatments were of particular note. Bristol Myer Squibb’s Abecma (Idecabtagene Vicleucel) gained Conditional Marketing Authorization: representing the first cell-based gene therapy to treat adult patients with multiple myeloma.

And Gilead’s Trodelvy (sacituzumab govitecan), a Trop-2-directed antibody-drug conjugate, was authorized as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease.

Outside of cancer, other key authorizations included Bylvay (the first treatment for progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older); Evrysdi (the first oral treatment for patients with certain types of spinal muscular atrophy, a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement); and Tavneos (a medicine to treat adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis, a rare type of inflammation of the blood vessels).

COVID-19 authorizations continued

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.

COVID-19 was a key priority for the EMA: with the use of rolling reviews helping authorize vaccines in a short a time as possible. Four vaccines have been authorized; and another four are currently under rolling review.

Associated with the authorized vaccines was the approval of new manufacturing sites and lines: with the number of approved manufacturing sites up from 19 to 52.

In November the first monoclonal antibodies to treat COVID-19 were approved.

Five negative opinions in 2021 

In 2021, the EMA’s Committee for Medical Products for Human Use (CHMP) adopted a negative opinion for five medicines. The most high-profile was its negative opinion for Biogen’s Alzheimer’s drug Aduhelm: which was approved by the FDA but failed to convince the CHMP of its benefit-risk balance.

Related topics: Markets & Regulations

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