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FDA Watch: Approvals for AbbVie, Roche; designations for Ironwood, Ascendis

Approvals and designations made by the U.S. Food and Drug Administration for the week ended June 8.

Approvals

* AbbVie Inc. and Roche Holding AG's Venclexta-Rituxan combination, for certain patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Venclexta is already approved to treat CLL or SLL.

* Roche's Rituxan, for adults with moderate to severe pemphigus vulgaris. The FDA previously granted Rituxan priority review, breakthrough therapy and orphan drug designations.

* Eli Lilly and Co. and Merck & Co. Inc.'s Alimta-Keytruda combination, for certain patients with non-small cell lung cancer. Alimta is already approved to treat different types of NSCLC.

* EDAP TMS SA's Focal One device, to view 3D images of the prostate and direct ultrasound waves to remove the targeted area. The company received 510(k) clearance.

* K2M Group Holdings Inc.'s Ozark cervical plate systems, to facilitate spinal balance in patients with degenerative disease, deformity, tumor or trauma.

* Insulet Corp.'s Omnipod Dash, an insulin management system. The company received 510(k) clearance, and plans to launch the product in early 2019.

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

Complete response letters

* Amgen Inc.'s ABP 980, a biosimilar version of Roche's breast cancer drug Herceptin. The company said it does not expect the rejection to impact its U.S. launch plan.

Priority review

* Roche's Hemlibra, for certain adults and children with hemophilia A. The application's target action date is Oct. 4.

Other designations

* Orphan drug, for Ironwood Pharmaceuticals Inc.'s olinciguat, to treat sickle cell disease.

* Orphan drug, for Ascendis Pharma A/S's TransCon PTH, to treat hypoparathyroidism.

* Rare pediatric disease, for Cellectar Biosciences Inc.'s CLR 131, to treat rhabdomyosarcoma. The FDA previously granted CLR 131 orphan drug status, as well as rare pediatric disease designation for neuroblastoma.

* Orphan drug, for Alnylam Pharmaceuticals Inc.'s ALN-TTRsc02, to treat transthyretin-mediated amyloidosis.