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Approvals for GSK, GE Healthcare; designations for Merck KGaA, Adaptimmune

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Approvals for GSK, GE Healthcare; designations for Merck KGaA, Adaptimmune

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Sept. 13.

Approvals

* GlaxoSmithKline PLC's Nucala as an add-on treatment for severe eosinophilic asthma in children six to 11 years old. Nucala was initially approved in 2015 for patients 12 years and older.

* General Electric Co.'s Critical Care Suite — developed by GE Healthcare Inc. — a mobile X-ray device that uses artificial intelligence to speed up the review of collapsed lung cases. The device received 510(k) clearance.

* Ardelyx Inc.'s Ibsrela for irritable bowel syndrome with constipation in adults.

* Xeris Pharmaceuticals Inc.'s ready-to-use glucagon rescue pen Gvoke for severe hypoglycemia in diabetes patients older than two years.

* Hamilton Thorne Ltd.'s Gynemed GM501 Wash media, for washing and handling human oocytes and embryos as they are prepared for certain procedures in the process of in vitro fertilization. The solution was granted 510(k) clearance.

* Axonics Modulation Technologies Inc.'s Axonics r-SNM system for fecal incontinence.

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

Priority review

* Horizon Therapeutics PLC's teprotumumab for active thyroid eye disease.

Fast track

* ProQR Therapeutics NV's QR-1123 to counter the underlying causes of autosomal dominant retinitis pigmentosa caused by the P23H mutation in the rhodopsin gene.

Breakthrough therapy

* Merck KGaA's tepotinib for metastatic non-small cell lung cancer in patients whose the MET exon 14 skipping mutations worsened after receiving platinum-based cancer therapy.

Orphan drug

* Adaptimmune Therapeutics PLC's ADP-A2M4 or MAGE-A4 SPEAR T cell therapy, to specifically target synovial sarcoma and myxoid/round cell liposarcoma.

* Akari Therapeutics PLC's nomacopan, for bullous pemphigoid.

* Acceleron Pharma Inc.'s sotatercept for pulmonary arterial hypertension.