EMA gives positive opinion on Novartis drug for Polymyalgia Rheumatica
What happened
The European Medicines Agency gave a positive opinion on Novartis' Cosentyx for the treatment of polymyalgia rheumatica (PMR) in adults. The opinion supports the drug's use for patients who have not responded adequately to steroids or who experience relapse during steroid tapering. This positive opinion was supported by results from the pivotal REPLENISH phase 3 trial.
From pmlive.com
Why it matters
If approved, Cosentyx would become the first interleukin-17A inhibitor available in Europe for PMR, a condition that currently has limited advanced treatment options. The drug offers an alternative to long-term steroid use, which carries risks such as osteoporosis and diabetes.
From pmlive.com
Who's involved
- European Medicines AgencyThe highest regulatory authority in the European Union that issued the positive opinion.
- NovartisThe pharmaceutical corporation that developed the drug Cosentyx.
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- NovartisSpeculative
Novartis could see increased revenue potential and market share in Europe if the European Commission grants final marketing authorization.
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The entities involved
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European Medicines Agency
highest regulatory authority on medicines in the European Union
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Novartis
Swiss-American multinational pharmaceutical corporation
Related events
- Oncopeptides AB's drug received a positive opinion from the EMA, leading to the European Commission making a final decision for the EU market.
- Novartis sought Swissmedic regulatory approval for a drug, which was co-funded by Sida and introduced first in Ghana.
- EMA validated marketing authorization and FDA accepted NDA for Pharvaris N.V.'s lead drug.
- EMA adopted a positive opinion and the European Commission granted marketing authorization for the drug Hopledo.
- Novartis' trial results are impacting Royalty Pharma's investment decisions.