CHMP approves 11 new drugs, rejects one

Several drugs from Danish developers have been appraised positively by the EMA's expert committee, the CHMP, during its November meeting. In total, 11 drugs have gone through the eye of the needle.

Photo: PIROSCHKA VAN DE WOUW/REUTERS / X06750

BY MIKKEL AABENHUS HEMMINGSEN, TRANSLATED BY DANIEL PEDERSEN

Published: 12.11.21 at 15:43

Novo Nordisk, Lundbeck and Ascendis Pharma count among the companies that have cause for celebration after this month's meeting at the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

The committee has thus nominated Novo Nordisk's weight loss drug Wegovy, Lundbeck's migraine infusion Vyepti and Ascendis Pharma's growth hormone Skytrofa for European patient use.

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"Real world" patient data documents the long-term effects of ALK vaccines

Data from ALK's React study, which is a retrospective real-world evidence study including more than 92,000 patients with respiratory allergies, have just been published in the journal The Lancet Regional Health – Europe. | Photo: ALK / PR

In the largest study ever of its kind, patient data from the "real world" documents the long-term effects of up to nine years of ALK vaccines. Up until now, it has not been possible to demonstrate these in ordinary clinical studies where the follow-up period is shorter, and the new knowledge could be a turning point in ALK's dialog about prices and subsidies with authorities and payers.