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Approval for AstraZeneca, Merck & Co.; designations for Chugai, Eiger

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 21.


* AstraZeneca PLC and Merck & Co. Inc.'s Lynparza, as maintenance therapy for women with certain types of ovarian, fallopian tube and peritoneal cancer. Lynparza is already approved to treat BRCA-mutated breast cancer and certain ovarian cancer mutations.

* Stemline Therapeutics Inc.'s Elzonris, to treat a rare blood disease known as blastic plasmacytoid dendritic cell neoplasm.

* Camurus AB and Braeburn Inc.'s Brixadi, to treat opioid use disorder.

* Veloxis Pharmaceuticals A/S' Envarsus XR, in combination with other immunosuppressants, to prevent organ rejection in de novo kidney transplant patients.

* Acorda Therapeutics Inc.'s Inbrija, to treat symptoms of Parkinson's.

* IRadimed Corp.'s 3883 MRI-compatible invasive blood pressure module, to directly measure blood pressure in patients under intensive care, or being transported within a hospital. The module is for use with IRadimed's vital signs monitoring system.

* Teva Pharmaceutical Industries Ltd.'s ProAir Digihaler, to treat a type of asthma in children and adults.

* Cutera Inc.'s enlighten laser platform, to clear acne scars. Cutera branded the new application PICO Genesis FX. The enlighten laser platform is already approved to remove tattoos and treat benign pigmented lesions.

* Arch Therapeutics Inc.'s AC5 topical gel, to manage partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers and surgical wounds. Arch Therapeutics said it would delay the product's commercialization until the first half of 2019.

* Mylan NV's generic version of Allergan plc's inflammatory bowel disease therapy Canasa Rectal Suppository. The drug, also called mesalamine rectal suppository, is already approved to treat mildly to moderately active ulcerative proctitis.

* Shire plc's Motegrity, for adults with chronic idiopathic constipation. Motegrity is marketed as Resolor in the EU.

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

Complete response letters

* ADMA Biologics Inc.'s RI-002, meant to treat primary humoral immunodeficiency. ADMA Biologics said it will request a meeting to clarify and respond to issues raised by the FDA.

Fast track

* Gritstone Oncology Inc.'s Granite-001, for bowel cancer.

* Equillium Inc.'s EQ001, for acute graft versus host disease.

* Valneva SE's VLA1553, to prevent chikungunya.

Breakthrough therapy

* Chugai Pharmaceutical Co. Ltd.'s satralizumab, for neuromyelitis optica and neuromyelitis optica spectrum disorders. Chugai is a unit of Roche Holding AG.

* Eiger BioPharmaceuticals Inc.'s lonafarnib, for Hutchinson-Gilford progeria syndrome and progeroid laminopathies, as well as Hepatitis delta virus infection. The FDA previously granted lonafarnib orphan-drug status for progeria. Eiger licensed the drug from Merck & Co.

* Vertex Pharmaceuticals Inc.'s VX-150, for certain patients experiencing moderate to severe acute pain.

Other designations

* Orphan drug, for Mustang Bio Inc.'s MB-102, for blastic plasmacytoid dendritic cell neoplasm.

* Orphan drug, for AVROBIO Inc.'s AVR-RD-01, for Fabry disease.