2023-04-27 06:34:36 ET
- A committee of the European Medicines Agency (EMA) recommended the approval of Novartis ( NYSE: NVS ) Cosentyx (secukinumab) to treat adults with active moderate to severe hidradenitis suppurativa (HS).
- HS is a condition in which small, painful lumps form under the skin, usually in areas where the skin rubs together such as the armpits and groin.
- The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the drug based on data from two trials phase 3 trials called SUNSHINE and SUNRISE.
- The European Commission (EC), which generally follows the opinion of the CHMP, will now make a decision on the application.
- The Swiss pharma giant expects EC's decision within two months. The drug is also under review in the U.S. with a decision by the FDA expected later this year.
- In February, Novartis had abandoned its plans to develop Cosentyx for active peripheral spondyloarthritis.
For further details see:
Novartis Cosentyx gets EMA panel backing to treat painful skin disorder