FDA and EC Approve Novartis’ Psoriasis Drug Cosentyx

The US Food and Drug Administration (FDA) and the European Commission (EC) approved Novartis’ biologic Cosentyx (secukinumab) as a treatment for psoriasis.

Today, Novartis announced that it has received FDA-approval and recently received EU approval for the drug, making it the first drug in the interleukin-17A (IL-17A) inhibitor class to be approved for psoriasis in both the US and Europe. Specifically, the drug is approved as a first-line systemic therapy for the treatment of moderate-to-severe psoriasis.

Currently, all other biologic agents for psoriasis, including TNF blockers such as Amgen/Pfizer’s Enbrel (etanercept) and AbbVie’s Humira (adalimumab) as well as Janssen’s IL-12/23 inhibitor Stelara (ustekinumab), are reserved for second-line use in the EU.

In a Phase III program, Novartis’ Cosentyx significantly improved skin clarity, a key treatment goal for psoriasis patients, compared to placebo and proved superior to Stelara and Enbrel. Additionally, in the program the overall safety profile of Cosentyx was favorable, with minimal differences seen between Enbrel and Stelara.

The FDA’s approval follows a unanimous vote by the FDA Advisory Committee.

“The FDA’s approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only approved treatment targeting the IL-17 pathway, which is proven to play a key role in the development of plaque psoriasis,” said David Epstein, Division Head, Novartis Pharmaceuticals. “This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin.”

The EC granted approval of Cosentyx on Monday.

“With this groundbreaking news from the European Commission, clear skin may now be a reality for patients living with psoriasis,” said Epstein. “Nearly half of psoriasis patients are not content with current therapies, including biologic treatments, showing a significant unmet need for patients. Cosentyx, with a first-line systemic indication for treatment of psoriasis will provide patients a better chance of achieving clear or almost clear skin.”

In addition to the US and EU, Cosentyx has been approved in Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).

Psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain. Psoriasis is associated with significant impairment of physical and psychological quality of life. It affects up to three percent of the world’s population. Although current therapies for psoriasis exist, there is a need for new treatments, since roughly half of psoriasis patients are not content with current therapies, including biologic treatments.

Source: Novartis AG

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