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FDA Watch: Approvals for Roche, Pfizer; priority review for J&J, Novartis

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 22.


* Roche Holding AG's Perjeta, in combination with Herceptin and chemotherapy, for post-surgical treatment of HER2-positive early breast cancer at high risk of recurrence. The combination is already approved for breast cancer patients whose disease has spread to different parts of the body and who have not received anti-HER2 therapy or chemotherapy.

* Pfizer Inc.'s Bosulif, for adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia. The company is developing the drug under a collaboration with Avillion LLP. Bosulif is already approved to treat adults with certain leukemia types.

* Merck & Co. Inc. and Pfizer's Steglatro, as a single therapy and in fixed-dose combinations, for type 2 diabetes. The companies plan to launch the drug in early 2018.

* Bristol-Myers Squibb Co.'s Opdivo, for post-surgical treatment of patients with a certain type of melanoma. The drug is already approved to treat certain cancer types.

* Quidel Corp.'s Solana GBS Assay test, for detecting Group B streptococcus in women nearing childbirth. The company received 510(k) clearance.

* La Jolla Pharmaceutical Co.'s Giapreza, for increasing blood pressure in adults with septic or other distributive shock. The company plans to launch the drug in March 2018.

* Aeterna Zentaris Inc.'s Macrilen, for the evaluation of adult growth hormone deficiency. The company plans to launch the drug in the first quarter of 2018.

* Carmel Biosciences Inc.'s Prexxartan oral solution, for high blood pressure and congestive heart failure. The company licensed the drug to Medicure Inc., which expects to launch Prexxartan in the first half of 2018.

* Exelixis Inc.'s Cabometyx, for advanced renal cell carcinoma. The drug is already approved to treat previously treated patients with advanced renal cell carcinoma.

* Spark Therapeutics Inc.'s Luxturna, for children and adults with biallelic RPE65 mutation-associated retinal dystrophy. The drug was awarded the orphan designation by the U.S. FDA in January, and later the regulator granted a priority review for the company's biologics license application.

* CYBERDYNE Inc.'s hybrid assistive limb, or HAL device, for patients with lower limb disorders or weakening legs. The company received 510(k) clearance.

* Aerie Pharmaceuticals Inc.'s Rhopressa, for lowering elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. An FDA advisory panel previously voted in favor of the drug.

* Biotricity Inc.'s Bioflux device, for remotely monitoring and diagnosing patients with cardiovascular coronary heart disease. The company received 510(k) clearance.

* Spectral Medical Inc.'s Spectral Apheresis Machine, for continuous renal replacement therapy and therapeutic plasma exchange. The company received 510(k) clearance.

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

Priority review

* Johnson & Johnson's apalutamide, for men with nonmetastatic castration-resistant prostate cancer. The application's Prescription Drug User Fee Act date is April 2018.

* Novartis AG's Tafinlar-Mekinist combination, for post-surgical treatment of patients with stage 3 melanoma whose tumors express the BRAF V600E/K mutation. The combination previously secured breakthrough therapy designation, and is already approved for certain skin and lung cancer types.

* AstraZeneca PLC's Tagrisso, for metastatic non-small cell lung cancer. The drug previously secured breakthrough therapy designation.


* Ovid Therapeutics Inc.'s OV101, for Angelman syndrome. The drug also secured orphan designation to treat Fragile X syndrome.

Breakthrough therapy

* Merck KGaA and Pfizer's Bavencio, in combination with Inlyta, to treat advanced kidney cancer. The companies are developing the drug under a strategic alliance. Bavencio is already approved to treat certain cancer types.

Other designations

* Regenerative medicine advanced therapy designation for Mesoblast Ltd.'s mesenchymal precursor cell therapy to treat heart failure patients with left ventricular systolic dysfunction and left ventricular assist devices. The designation also allows for priority review. The company is expecting results from a phase 2b trial of the therapy by the first quarter of 2018.

* Qualified infectious disease product designation for Basilea Pharmaceutica AG's ceftobiprole to treat bloodstream infections caused by staphylococcus aureus bacteria. The company said it is preparing two phase 3 trials of the drug.

* Orphan drug designation for ProMetic Life Sciences Inc.'s Ryplazim to treat idiopathic pulmonary fibrosis.

* Orphan drug expansion for Achillion Pharmaceuticals Inc.'s ACH-4471, for C3 glomerulopathy. The drug's prior designation was for paroxysmal nocturnal hemoglobinuria.