logo
Plus   Neg
Share
Email

Novartis Gets FDA Approval For Cosentyx Label Update - Quick Facts

Swiss drug major Novartis AG (NVS) said that the U.S. Food and Drug Administration or FDA has approved a label update for Cosentyx or secukinumab, the first interleukin-17A or IL-17A inhibitor approved to treat moderate-to-severe plaque psoriasis.

The updated label includes Cosentyx data in moderate-to-severe scalp psoriasis - one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients.

The company said that the label update is effective in the U.S. immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.

The updated label for Cosentyx in scalp psoriasis addresses an important unmet need. Scalp psoriasis can be challenging to treat with topical agents or phototherapy due to the presence of hair and other factors. Approximately half of all 125 million patients with psoriasis suffer from scalp psoriasis.

The label update is based on 12-week primary endpoint results from the SCALP study of moderate-to-severe scalp psoriasis where Cosentyx demonstrated superior efficacy compared to placebo.

Psoriasis is a distressing and painful autoimmune disease that affects more than 125 million people worldwide. It is a debilitating condition associated with a significant emotional and physical daily burden.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Amazon.com Inc. said it plans to open a new corporate office in Manchester in 2019 and create more than 1,000 highly-skilled jobs in the UK. As part of the ramp up of its UK investment, Amazon will increase the capacity of its Scotland Development Centre and Cambridge Development Centre. The company's 1,000 new staffers will work on research and development in the UK. Ford will launch its new "Built Ford Proud" U.S. advertising campaign this weekend as the automaker grapples with slowing sales and plans to restructure its operations in order to cut costs. The ad campaign will highlight Ford's 115-year history of manufacturing cars and comes as the automaker intends to replace 75 percent of its U.S. lineup by 2020. The Procter & Gamble Company (PG) reported first-quarter core earnings per share of $1.12, an increase of three percent versus the prior year, as benefits from a lower tax rate due to implementation of the U.S. Tax Act was partially offset by a reduction in operating margin, driven largely by negative...
Follow RTT