New FDA Specialty Approvals
✦ Feb. 10: The FDA granted final approval to Eagle Pharmaceuticals, Inc.’s Pemfexy (pemetrexed) for the treatment of people with locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin. The drug, to which the FDA granted tentative approval in 2017, is a branded alternative to Eli Lilly and Company’s Alimta (pemetrexed). The two drugmakers reached a settlement in patent litigation on Dec. 13, 2019, that will allow Pemfexy to launch with a three-week supply on Feb. 1, 2022, then an uncapped entry on April 1, 2022. Dosing for the intravenous injection depends on the indication. For more information, visit https://bit.ly/2vkZBSi.
✦ Feb. 18: The FDA approved a new dosage form for Procysbi (cysteamine bitartrate) for the treatment of people at least one year old with nephropathic cystinosis. The Horizon Pharma plc drug is now available in delayed-release oral granules, as well as capsules. The granules, also known as microbeads, will be available in packets of 75 mg and 300 mg strengths in the first half of 2020. The agency initially approved the capsule in 1994. Dosing is weight-based. Website Drugs.com lists the price of 250 75 mg delayed-release capsules as $26,454. Visit www.procysbi.com.