EU green light for more than 50 new drugs in 2021

The European Medicines Agency (EMA), the EU’s drug regulator, has now approved a total of 52 new medicines for human use in the first seven months of the year. The agency also recommended the extension of licenses for 50 existing medicines, allowing these products to be used for new indications.

At its summer meeting in late July, the EMA’s key committee on human medicines – the CHMP – adopted a positive opinion for Nexviadyme (avalglucosidase alfa), intended for the treatment of glycogen storage disease type II (Pompe disease).

The CHMP recommended granting a marketing authorisation for the hybrid medicine Imatinib Koanaa (imatinib), intended for the treatment of leukaemia and gastrointestinal stromal tumours. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

Extensions of indication were granted for Deltyba, Ultomiris, Volibris and Vosevi, meaning that more than 100 positive opinions have been adopted by the Committee during a busy year in which COVID-19 vaccines and therapies have thrust the EMA into the spotlight.

The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Nouryant (istradefylline). Nouryant was intended as a medicine to treat adults with Parkinson’s disease.

Meanwhile, the Agency announced that it has started evaluating the use of RoActemra in hospitalised adults with severe COVID-19. The anti-inflammatory drug has been on the market for more than a decade and is proven to block the action of interleukin-6 – a substance produced by the body’s immune system in response to inflammation.

The CHMP is conducting an accelerated assessment to determine whether to grant an extension that would allow the product to be used to treat hospitalised adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra oxygen or mechanical ventilation.