- The FDA on Wednesday granted approval to Novartis' Cosentyx (secukinumab).
- Cosentyx has been cleared to treat adults with moderate-to-severe plaque psoriasis.
- The drug, a likely blockbuster, was already approved in Japan earlier this month (although the specific approved inidications there were for treatment of psoriasis vulgaris and psoriatic arthritis in patients who have not responded to other treatments). It also won EU approval earlier this week.
As BioPharma Dive has previously reported, Cosentyx is expected to be one of the biggest drug launches of 2015, with potential sales this year of $133 million and in 2020 of $1.1 billion.
It's also the latest approval in the scorching hot monoclonal antibody therapeutic class (Cosentyx is an anti-IL-17A mAb, the first of its kind to win approval). That class includes pricey specialty meds for conditions ranging from cancer (PD-1 inhibitors like Keytruda and Opdivo) to high cholesterol (alirocumab and evolocumab).
But Novartis has its work cut out for it. Cosentyx will be going up against old mainstays like AbbVie's Humira, the top-selling drug in the world, Amgen's Enbrel, and J&J's Stelara.