Brief: Novartis Says CHMP Of European Medicines Agency (EMA) Adopted Positive Opinion Recommending Marketing Authorization For Cosentyx
BRIEF-Novartis Says CHMP Of European Medicines Agency (EMA) Adopted Positive Opinion Recommending Marketing Authorization For Cosentyx Sept 18 (Reuters) - NOVARTIS AG NOVN.S:
NOVARTIS ANNOUNCED TODAY THAT COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OF EUROPEAN MEDICINES AGENCY (EMA) HAS ADOPTED A POSITIVE OPINION RECOMMENDING MARKETING AUTHORIZATION FOR COSENTYX(®)
NOVARTIS ANNOUNCED TODAY THAT COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OF EUROPEAN MEDICINES AGENCY (EMA) HAS ADOPTED A POSITIVE OPINION RECOMMENDING MARKETING AUTHORIZATION FOR COSENTYX(®) (SECUKINUMAB) IN POLYMYALGIA RHEUMATICA (PMR).⁸
OPINION SUPPORTS COSENTYX USE FOR TREATMENT OF PMR IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO STEROIDS OR WHO EXPERIENCE RELAPSE DURING STEROID TAPER
POSITIVE CHMP OPINION IS SUPPORTED BY RESULTS FROM PIVOTAL REPLENISH PHASE III TRIAL
FOLLOWING CHMP RECOMMENDATION FOR APPROVAL, EUROPEAN COMMISSION (EC) IS EXPECTED TO ISSUE A FINAL DECISION WITHIN APPROXIMATELY TWO MONTHS.
Source text: ID:nGNE1fLwvK
Further company coverage: NOVN.S
(Gdansk Newsroom)
((Gdansk.newsroom@thomsonreuters.com; +48 58 7696600;))
Recent news on Novartis AG
See all newsNovartis AG expected to post earnings of $2.27 a share - Earnings Preview
AbbVie's skin disease drug reduces lesions in trial, company eyes weight-loss combination (updated)
AbbVie's skin disease drug reduces lesions in trial, company eyes weight-loss combination
Brief: Novartis Receives European Commission Approval For Cosentyx
Insight: How cheap Chinese antibiotics threaten Europe's last major penicillin plant