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Approvals for Roche, AbbVie; designations for AstraZeneca, Akari Therapeutics

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Approvals for Roche, AbbVie; designations for AstraZeneca, Akari Therapeutics

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Aug. 16.


* Roche Holding AG's Rozlytrek for non-small cell lung cancer that has spread to other parts of the body and who express ROS1.

* Roche's Rozlytrek, for patients whose solid tumors have certain gene rearrangements called NTRK gene fusion, that do not have a known acquired resistance mutation. The drug received accelerated approval for this indication.

* AbbVie Inc.'s Rinvoq, for adults with moderately to severely active rheumatoid arthritis who cannot take or have had an inadequate response to the commonly used immunosuppressive drug methotrexate.

* Celgene Corp.'s Inrebic for patients with intermediate or high-risk myelofibrosis. The approval was given to Celgene's life sciences arm Impact Biomedicines Inc.

* Zimmer Biomet Holdings Inc.'s product called the Tether, for children with scoliosis. The treatment got clearance under the FDA's humanitarian device exemption pathway.

* Expanded approval, for Edwards Lifesciences Corp. Sapien 3 and Sapien 3 Ultra along with Medtronic PLC's CoreValve Evolut R and CoreValve Evolut PRO transcatheter heart valves for patients with aortic stenosis who are at low risk of open-heart surgery.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: Associated Press

Fast track

* Windtree Therapeutics Inc.'s istaroxime for acute heart failure.

* Akari Therapeutics PLC's nomacopan for hematopoietic stem cell transplant associated thrombotic microangiopathy, or HSCT-TMA, in children.

Breakthrough therapy

* AstraZeneca PLC's Calquence as a single therapy for adults with chronic lymphocytic leukemia.

Other designations

* Qualified infectious disease product, for Daré Bioscience Inc.'s antibacterial gel DARE-BV1 for bacterial vaginosis.