FDA Specialty Approvals

FDA Approves Alzheimer’s Agent Leqembi Shortly After Release of Congressional Aduhelm Report

Less than two years after the FDA approved the first treatment for Alzheimer’s that was aimed at targeting the underlying disease process, it has approved a second similar agent. Payers are likely to cover the drug, one industry expert says, but they almost certainly will try to place restrictions on their coverage.

On Jan. 6, the FDA gave accelerated approval to Eisai Co., Ltd. and Biogen Inc.’s Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease in people with mild cognitive impairment or mild dementia stage of disease. People must have confirmed presence of amyloid beta pathology before starting treatment. The agency gave the humanized immunoglobulin gamma 1 monoclonal antibody fast track, priority review and breakthrough therapy designations.

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New FDA Specialty Approvals

✦ July 30: The FDA granted premarket approval to Pillar Biosciences, Inc.’s ONCO/Reveal Dx Lung and Colon Cancer Assay as a companion diagnostic for all FDA-approved epidermal growth factor receptor tyrosine kin...
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New FDA Specialty Approvals

✦ July 9: The FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who ...
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New FDA Specialty Approvals

✦ June 7: The FDA granted another indication to Alexion Pharmaceuticals, Inc.’s Ultomiris (ravulizumab-cwvz) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in children at least 1 month old and ad...
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New FDA Specialty Approvals

✦ May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of loca...
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New FDA Specialty Approvals

✦ May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of loca...
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New FDA Specialty Approvals

✦ April 6: The FDA approved a new dosing regimen for Eli Lilly and Co.’s Erbitux (cetuximab) of 500 mg/m2 as a 120-minute infusion every two weeks as a single agent or in combination with chemotherapy for people...
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New FDA Specialty Approvals

✦ Feb. 3: The FDA gave accelerated approval to Merck KGaA unit EMD Serono, Inc.’s Tepmetko (tepotinib) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithel...
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New FDA Specialty Approvals

✦ Jan. 14: The FDA granted an additional indication to Pfizer Inc.’s Xalkori (crizotinib) to treat children at least 1 year old and young adults with relapsed or refractory, systemic anaplastic large cell lympho...
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New FDA Specialty Approvals

✦ Dec. 14: The FDA approved a new dosing time for Roche Group unit Genentech USA, Inc.’s Ocrevus (ocrelizumab) to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, ...
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