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(Bloomberg) -- Novartis AG won U.S. approval for the first in a new line of psoriasis drugs that aim to better treat the itchy, sometimes debilitating skin condition.
The Food and Drug Administration said it cleared the treatment to be called Cosentyx. The medicine, also known as secukinumab, is predicted to top $1 billion in sales by 2020 and will compete with other biologic drugs including AbbVie Inc.’s No. 1 seller, Humira, and Amgen Inc.’s best-selling Enbrel. The therapy was backed in November by European Commission health regulators.
About 7.5 million Americans have psoriasis, which is an autoimmune disease that can cause raised, red patches on the skin that are covered in dead skin cells, according to the National Psoriasis Foundation. The new type of drugs called interleukin inhibitors, which are also in development at Eli Lilly & Co. and in a partnership of Amgen and AstraZeneca Plc, are supposed to work faster and be more effective for the most serious patients.
Cosentyx is administered as an injection under the skin. It is intended for patients who are candidates for systemic therapy, treatment using substances that travel through the bloodstream, and ultraviolet light therapy, or a combination of both, the FDA said today in a statement.
Novartis, based in Basel, Switzerland, studied secukinumab against Thousand Oaks, California-based Amgen’s Enbrel and said it worked “significantly” better to clear the skin. The latest study pitting secukinumab against Johnson & Johnson’s Stelara showed Novartis’s drug worked better, the company said in a Dec. 12 statement.
Novartis’s drug may generate $1.1 billion in annual sales in 2020, according to the average of seven analysts’ estimates compiled by Bloomberg. AbbVie’s Humira had an estimated $12.6 billion in Humira sales in 2014 while Amgen and Pfizer Inc. are expected to report about $8.4 billion in Enbrel revenue.
Older treatments such as Enbrel and Humira block a protein called TNF that signals the body to create inflammation. Stelara targets proteins known as IL-12 and IL-23, while secukinumab goes after IL-17A, which only recently has been linked to psoriasis.
Most people with psoriasis have a mild version of the disease while 1 in 5 have moderate to severe psoriasis. The condition typically shows up in patches on the knees, elbows, scalp, hands and feet. Patients with mild cases try over-the- counter and prescription creams and those with more widespread cases take a generic drug called methotrexate.
Methotrexate has serious side effects such as the potential for liver and lung problems, damage to the lining of the mouth, stomach or intestines and an increased risk of developing lymphoma. Older biologic drugs also can cause serious side effects including infections and malignancies.
Patients taking Cosentyx may be at greater risk of getting an infection, according to the FDA. The most common side effects include diarrhea and upper respiratory infections, the agency said.
--With assistance from Simeon Bennett in Geneva.
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