Novartis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the grant of marketing authorization for Cosentyx® (secukinumab) in adults with active moderate to severe hidradenitis suppurativa, an inflammatory skin disease. The recommendation was based on results from two phase III trials which showed that patients who received Cosentyx® continued to improve beyond the primary endpoint analysis at week 16, with more than 55% of patients achieving a Hidradenitis Suppurativa Clinical Response at week 52.
Last year BioThera began phase III trials of BAT2306, biosimilar to Cosentyx®, in patients with moderate to severe plaque psoriasis.