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Approvals for Amgen, Roche; designations for Merck & Co., J&J

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Approvals for Amgen, Roche; designations for Merck & Co., J&J

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 6.

Approvals

* Amgen Inc.'s Avsola, a biosimilar of Johnson & Johnson's Remicade for autoimmune disorders including rheumatoid arthritis and psoriasis.

* Roche Holding AG's Tecentriq, in combination with chemotherapy drugs Abraxane and carboplatin, as an initial treatment for patients diagnosed with non-squamous non-small cell lung cancer that has spread to other parts of the body and whose tumors do not show mutations of the EGFR or ALK genes.

* HEC Pharm Co. Ltd., Biocon Ltd. and Sun Pharmaceutical Industries Ltd.'s first generic versions of Novartis AG's multiple sclerosis drug Gilenya for treating relapsing forms of multiple sclerosis in adult patients.

* Sight Diagnostics Ltd.'s Olo designed to conduct a complete blood count using two drops of blood.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: AP Photo

Priority review

* Merck & Co. Inc.'s Keytruda for the additional indication of treating patients whose high-risk, non-muscle invasive bladder cancer has carcinoma in-situ and may or may not have papillary tumors. These patients have also been unresponsive to an immunotherapy known as Bacillus Calmette-Guerin and are ineligible or chose to not have their bladders surgically removed.

Fast track

* ViiV Healthcare Ltd.'s fostemsavir, in combination with other antiretroviral drugs to treat adults with multidrug-resistant HIV-1 infection who do not show virus suppression due to resistance or intolerance to other medicines.

* Alector Inc.'s AL001 for patients with frontotemporal dementia carrying specific genetic mutations in the granulin gene.

Breakthrough therapy

* Bristol-Myers Squibb Co.'s Orencia for preventing graft-versus-host disease following a stem cell transplantation.

* ViiV Healthcare's fostemsavir in combination with other antiretroviral drugs to treat adults with multidrug-resistant HIV-1 infection who do not show virus suppression due to resistance or intolerance to other medicines.

* Johnson & Johnson's JNJ-4528 for patients with relapsed or refractory multiple myeloma who have previously undergone treatment.

Other designations

* Regenerative medicine advanced therapy designation, for Adaptimmune Therapeutics PLC's ADP-A2M4 for synovial sarcoma.

* Orphan drug, for Tetra Bio-Pharma Inc.'s Caumz for advanced hepatocellular carcinoma.

* Orphan drug, for Aptevo Therapeutics Inc.'s APVO436 for acute myelogenous leukemia.