Novartis gets FDA approval for psoriasis drug
pharmafile | January 22, 2015 | News story | Sales and Marketing | Cosentyx, European Commission, FDA, Novartis, Secukinumab, psoriasis
The US Food and Drug Administration (FDA) has shown Novartis’ skin condition drug Cosentyx the green light to treat patients with moderate-to-severe plaque psoriasis.
Cosentyx (secukinumab) is the first approved human monoclonal antibody (mAb) that is administered as an injection under the skin.
The medication is for adult patients who are candidates for systemic therapy – a drug that is absorbed into the bloodstream and distributed to all parts of the body. The nod by the FDA follows this month’s European Commission (EC) approval of the treatment.
“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,” comments David Epstein, who is the division head at Novartis.
“This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin.”
The mAb selectively binds to interleukin IL-17A – a cytokine, or small protein, that acts as a potent mediator in delayed-type reactions by increasing chemokine production in various tissues.
Approval was based on the efficacy and safety outcomes from 10 Phase II and III studies which included just under 4,000 people. Results of the studies demonstrated that the drug produced clearer skin in the majority of participants and had an acceptable safety profile.
According to Bloomberg the treatment is predicted to top $1 billion in sales by 2020. Similar drugs in development from rival pharma firms include offerings by Eli Lilly, along with Amgen and AstraZeneca.
Psoriasis affects more than 125 million people worldwide, it is a chronic immune-mediated disease characterised by raised, red patches covered with a silvery white build-up of dead skin cells which can cause itching, scaling, and pain.
Plaque psoriasis is the most common form of the ailment and additionally, patients with the disease are subject to an increased risk of encountering other chronic illnesses such as cancers of the lung, bronchus and upper gastrointestinal tract.
Aside from psoriasis, Cosentyx is also in clinical trials for the treatment of psoriatic arthritis (PsA) and ankylosing spondylitis. Global regulatory applications for the skin condition drug are planned for 2015.
Tom Robinson
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