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Horizon's (HZNP) sBLA for Krystexxa Gets FDA Priority Review

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Horizon Therapeutics plc (HZNP - Free Report) announced that the FDA has granted priority review to its supplemental biologics license application (sBLA) seeking approval for combination use of its marketed drug, Krystexxa. The sBLA is seeking the approval of Krystexxa plus methotrexate to treat people living with uncontrolled gout.

Krystexxa is currently approved as a monotherapy for the treatment of adult patients with chronic gout refractory to conventional therapies, also called uncontrolled gout.

With the FDA granting priority review to the sBLA, a decision from the regulatory body is expected on Jul 7, 2022.

Horizon submitted the sBLA for the label expansion of Krystexxa to the FDA in January.

Shares of Horizon have decreased 8.5% in the year so far compared with the industry’s decline of 18.3%.

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The above sBLA filling was based on data from the MIRROR randomized clinical study, which evaluated Krystexxa plus methotrexate in patients with uncontrolled gout. In October 2021, Horizon announced positive top-line data from the above study, which showed that 71% of patients who received treatment with Krystexxa plus methotrexate achieved a complete serum uric acid (sUA) response, which is defined as sUA<6 mg/dL, at least 80% of the time during month six.

No new safety concerns were identified from the study.

Per the company, a certain number of patients treated only with Krystexxa develop anti-drug antibodies, which can limit the effectiveness of their treatment. However, recent data suggest that treatment with Krystexxa plus methotrexate, an immunosuppressant often prescribed by rheumatologists, might help prevent such anti-drug antibodies, in a way enabling more patients to achieve a durable response to therapy.

Krystexxa is an important top-line driver for Horizon. The drug generated sales worth $565.5 million in 2021, reflecting an increase of 39% year over year. If approved for use in combination with methotrexate, the drug will become eligible to serve a broader patient population and boost sales further in 2022 and beyond.

Zacks Rank & Stocks to Consider

Horizon currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Athersys, Inc. (ATHX - Free Report) , Kaleido Biosciences, Inc. and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Athersys’ earnings estimates have been revised 21.7% upward for 2022 over the past 60 days. The VRTX stock has gained 10.6% in the past year.

Earnings of Athersys have surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.

Kaleido Biosciences’ loss per share estimates have narrowed 11.3% for 2022 over the past 60 days.

Earnings of Kaleido Biosciences have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.

Vertex’s earnings estimates have been revised 9% upward for 2022 over the past 60 days. The VRTX stock has gained 7.2% year to date.

Vertex’s earnings have surpassed estimates in each of the trailing four quarters.