Ohtuvayre for COPD, Tepylute for Breast and Ovarian Cancer, Epkinly for R/R FL, Sofdra for Primary Axillary Hyperhidrosis, Wakix for Narcolepsy, PiaSky for PNH, Efgartigimod for CIDP, IBI343 for Pancreatic Cancer

New FDA Approvals

Do you work for a CME company that needs urgent medical writing assistance? We can help. Visit nascentmc.com - The FDA has approved ensifentrine (Ohtuvayre) as an inhaled maintenance therapy for adults with COPD. Ohtuvayre is the first new mechanism of action for COPD treatment in over two decades, offering anti-inflammatory and bronchodilatory effects to improve lung function and reduce symptoms without the side effects of inhaled corticosteroids. The approval was based on Phase 3 trials showing significant improvement in lung function and fewer exacerbations, granted to Verona Pharma.

- The FDA has approved thiotepa (Tepylute) for breast and ovarian cancer treatment. This new ready-to-dilute formulation saves preparation time and reduces risks, offering benefits like less-invasive treatment options. Breast cancer affects 1 in 8 women, while ovarian cancer has poorer outcomes due to late detection; the approval emphasizes Tepylute's ease of preparation and was granted to Amneal Pharmaceuticals.

- The FDA has approved epcoritamab-bysp (EPKINLY) for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of prior therapy. EPKINLY is the first T-cell engaging bispecific antibody for this indication, providing a new option for patients with limited treatment choices. The approval was based on the EPCORE® NHL-1 clinical trial, showing a high overall response rate, granted to AbbVie.

- The FDA has approved sofpironium topical gel (Sofdra) for treating primary axillary hyperhidrosis in adults and children aged 9 and older. Sofdra, an anticholinergic agent, reduces sweat production and significantly improves quality of life. The approval, based on two phase 3 studies showing significant improvement in sweat production, was granted to Botanix Pharmaceuticals, with expected availability in late 2024.

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- The FDA has approved pitolisant (Wakix) for treating excessive daytime sleepiness (EDS) in pediatric patients with narcolepsy. Pitolisant, a first-in-class treatment targeting the histamine system, was previously approved for adults with narcolepsy. The approval, based on a Phase 3 study, was granted to Harmony Biosciences.

- The FDA has approved crovalimab-akkz (PiaSky) for treating paroxysmal nocturnal hemoglobinuria (PNH) in patients aged 13 and older. Crovalimab, a complement C5 inhibitor, provides sustained complement inhibition through low-dose administration. The approval, based on efficacy in maintaining complement inhibition, was granted to Genentech, Inc.

- The FDA has approved efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Vyvgart Hytrulo, previously approved for generalized myasthenia gravis, demonstrated effectiveness in a two-stage study showing significant improvement in patient outcomes. The approval was granted to Argenx.

- The FDA has granted fast track designation to IBI343 for treating advanced pancreatic ductal adenocarcinoma (PDAC) that has relapsed or is refractory to one prior therapy. IBI343 is a monoclonal antibody-drug conjugate targeting CLDN18.2-expressing tumor cells. The designation, based on a phase 1 trial showing a 40% overall response rate, was granted to Innovent Biologics.