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AstraZeneca's (AZN) Ultomiris sBLA Gets FDA Priority Review

The FDA accepts and grants priority review to AstraZeneca's (AZN) sBLA for Ultomiris for treating adults with generalized myasthenia gravis. A decision is expected in the second quarter of 2022.

This story originally appeared on Zacks

AstraZeneca PLC AZN has announced that the FDA has accepted the supplemental biologics license application (sBLA) for its long-acting C5 complement inhibitor, Ultomiris (ravulizumab), for the treatment of adult patients with generalized myasthenia gravis (gMG), a rare autoimmune neuromuscular disease that causes loss of muscle function and severe weakness.

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With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected during the second quarter of 2022. The FDA set the Prescription Drug User Fee Act date after using a rare disease priority review voucher by Alexion – AstraZeneca’s Rare Disease group.

The above sBLA was based on positive data from the phase III study that evaluated Ultomiris for treating gMG. The study showed that treatment with Ultomiris significantly improved functional activities as measured by myasthenia gravis-activities of daily living profile. Also, Ultomiris showed compelling efficacy as early as week 1 and sustained the same for 52 weeks.

Per the company, the study results showed that Ultomiris may help a broader range of patients including those with milder symptoms or who are in the earlier days of their treatment journey.

Ultomiris is currently under review in the European Union and Japan for the treatment of gMG.

Shares of AstraZeneca have rallied 13.9% so far this year compared with the industry’s growth of 18.8%.

Zacks Investment ResearchImage Source: Zacks Investment Research

We remind investors that Ultomiris was added to AstraZeneca’s portfolio following the acquisition of Alexion Pharmaceuticals in July 2021. The drug is approved for treating paroxysmal nocturnal hemoglobinuria (“PNH”) and atypical hemolytic uremic syndrome (aHUS) in adults as well as pediatric (one month of age and older) patients. Both PNH and aHUS are ultra-rare diseases.

In the third quarter of 2021, Ultomiris generated sales worth $297 million, reflecting a pro rata increase of 31%. The drug has seen a strong uptake since its launch.

Label expansions of the drug to include a broader patient population should further boost sales in the days ahead.

Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the healthcare sector include GlaxoSmithKline plc GSKEndo International plc ENDP and Repligen Corporation RGEN. While GlaxoSmithKline currently holds a Zacks Rank #2 (Buy), Endo International and Repligen sport a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

GlaxoSmithKline’s earnings estimates have been revised 8.5% upward for 2021 and 6.2% for 2022 over the past 60 days. The stock has rallied 17.8% year to date.

GlaxoSmithKline’s earnings surpassed estimates in two of the trailing four quarters, missed the same once and matched it once.

Endo International’s earnings estimates have been revised 22.4% upward for 2021 and 9.8% for 2022 over the past 60 days.

Endo International’s earnings surpassed estimates in each of the trailing four quarters.

Repligen’s earnings estimates have been revised 5.1% upward for 2021 and 5.9% for 2022 over the past 60 days. The stock has rallied 39.6% year to date.

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

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