FDA declines to approve Sobi's gout therapy on concerns over manufacturing
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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
June 26 (Reuters) - The U.S. Food and Drug Administration declined to approve Swedish drugmaker Sobi's therapy to treat uncontrolled gout, a common form of inflammatory arthritis, the company said on Friday.
In its so-called complete response letter, the FDA asked the company to provide more data, mainly related to manufacturing controls and deficiencies at contract manufacturing facilities.
The FDA did not identify any safety or efficacy concerns, the company said.
The Stockholm-based company said it will request a meeting with the FDA to discuss resubmission and work with the contract manufacturing organizations to address the deficiencies.
Gout is a common form of arthritis known for sudden attacks of intense pain, swelling and tenderness in the joints. It is caused by high levels of uric acid accumulating around the joints and other tissues.
Uncontrolled gout is a condition in which uric acid levels remain high and symptoms are not well-controlled despite treatment.
Sobi's treatment, chemically known as nanoencapsulated sirolimus plus pegadricase, or NASP, is a four-week infusion therapy designed to reduce the level of uric acid in the blood.
The company estimates about 200,000 people in the U.S. suffer from uncontrolled gout.
Results from late-stage studies showed the therapy kept uric acid levels below the target of 6 milligrams per deciliter, a safe range to help prevent gout symptoms, for at least 80% of the sixth month of treatment.
Amgen's Krystexxa, an infusion given every two weeks, is the only FDA-approved medication for uncontrolled gout.
Other treatments for gout include nonsteroidal anti-inflammatory drugs, colchicine and corticosteroids.
(Reporting by Sneha S K and Puyaan Singh in Bengaluru; Editing by Leroy Leo and Sahal Muhammed)
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