Saturday, July 13, 2024

Gout Drug for Chronic Treatment: Sobi Begins Rolling FDA Filing

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Gout patients with refractory chronic conditions that do not respond to existing treatments may soon have a new option, as Sweden’s Sobi has initiated a rolling biologics license application (BLA) in the United States for SEL-212.

For patients who suffer from gout and find no relief using standard therapies, daily life can be an agonizing and debilitating experience. Gout, a painful form of inflammatory arthritis, is caused by elevated levels of uric acid in the blood. This condition results in uric acid crystals being deposited in and around the joints, leading to swelling, discoloration, and often excruciating pain.

Gout Prevalence Rises with Increasing Chronic Conditions in Developed Nations

Gout affects about one in 40 people in developed nations and is becoming more prevalent due to the increasing incidence of risk factors such as high blood pressure and other chronic conditions like diabetes, obesity, heart, and kidney diseases.

Current first-line therapies such as allopurinol and febuxostat can be very effective for many patients. However, approximately 1% of patients, according to FDA estimates, do not achieve the desired benefit from these drugs, while others may be intolerant to them.

Sobi’s FDA filing for SEL-212 is based on data from the pivotal DISSOLVE I and II studies. In these studies, around half of the patients treated with the highest dose of SEL-212 achieved target uric acid levels of 1.5 mg/dL or lower for at least 80% of the six months following the start of treatment. The current treatment goal for gout is to reduce uric acid levels to 6 mg/dL or less.

SEL-212 comprises a uricase enzyme (pegadricase) that breaks down uric acid in the blood. This enzyme is combined with an immune tolerance component (ImmTOR) designed to prevent the formation of antibodies against the enzyme, thereby prolonging the treatment’s efficacy.

gout

Gout Treatment SEL-212 Granted Fast-Track Review by FDA to Compete with Amgen’s Krystexxa

The FDA has granted SEL-212 a fast-track review, highlighting the urgent need for new treatment options for patients with chronic refractory gout. If approved, SEL-212 will compete with Amgen’s FDA-approved Krystexxa (pegloticase), another uricase-based therapy. Krystexxa was acquired by Amgen as part of its $28 billion takeover of Horizon Pharma, which closed last October. Amgen reported sales of $272 million for Krystexxa in 2023 and $235 million in the first quarter of this year.

Sobi licensed SEL-212 from Selecta Biosciences, now known as Cartesian Therapeutics, in June 2020 for $100 million upfront and milestone payments of up to $630 million. Sobi is responsible for the development, regulatory, and commercial activities for SEL-212 in all markets outside of China.

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Sobi has launched a rolling biologics license application (BLA) in the U.S. for SEL-212, aimed at treating refractory chronic gout unresponsive to current treatments. Gout, a form of inflammatory arthritis caused by elevated uric acid levels, affects approximately one in 40 people in developed countries. Rising cases are attributed to increasing risk factors like high blood pressure, diabetes, obesity, heart, and kidney diseases. While first-line therapies like allopurinol and febuxostat are effective for many, about 1% of patients do not benefit, and others may be intolerant.

Sobi’s FDA filing is backed by data from the DISSOLVE I and II studies, showing that half of the patients treated with the highest dose of SEL-212 reached uric acid levels of 1.5 mg/dL or lower for 80% of six months. SEL-212 combines a uricase enzyme (pegadricase) with an immune tolerance component (ImmTOR) to prevent antibody formation and extend efficacy. The FDA’s fast-track review underscores the need for new treatments for chronic refractory gout.

If approved, SEL-212 will compete with Amgen’s Krystexxa (pegloticase), acquired in Amgen’s $28 billion takeover of Horizon Pharma. Amgen reported sales of $272 million for Krystexxa in 2023 and $235 million in Q1 2024. Sobi licensed SEL-212 from Selecta Biosciences (now Cartesian Therapeutics) in June 2020 for $100 million upfront and up to $630 million in milestones, handling all development, regulatory, and commercial activities outside China.

Resource: Sobi, July 02, 2024

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