The FDA has recently approved five treatments, including new drugs, a new injectable formulation and expanded uses for two cancer and skin therapies. Here are the five to know:
- 1st-of-its-kind schizophrenia injection: The FDA approved Weltruza (Teva Pharmaceuticals), the first and only once-monthly subcutaneous long-acting injectable olanzapine, for adults with schizophrenia. It requires no loading doses, oral supplementation or post-injection monitoring. The approval was based on the phase 3 SOLARIS trial, which showed improvement in symptoms, illness severity and personal and social functioning. It comes in three strengths corresponding to oral olanzapine doses of 10, 15 and 20 milligrams and will be available in the coming weeks.
- 1st-of-its-kind treatment for symptomatic dermographism: The FDA approved Rhapsido (remibrutinib, Novartis), an oral BTK inhibitor, for adults whose symptoms are not controlled by H1 antihistamines. It is also the only prescription treatment approved for both chronic spontaneous urticaria and symptomatic dermographism when antihistamines fail. In the phase 3 REMODEL-1 and REMODEL-2 studies, 29.3% of patients on Rhapsido achieved the study’s measured response at week 12, compared with 14% on placebo.
- Drug for previously untreated blood cancers: The FDA approved Jaypirca (pirtobrutinib, Eli Lilly) on Oct. 2 for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion. In the BRUIN CLL-313 trial of 282 patients, median progression-free survival was not estimable with pirtobrutinib at a median follow-up of 28 months, compared with 33.5 months with bendamustine plus a rituximab product. Serious adverse reactions occurred in 28% of patients on pirtobrutinib. The recommended dose is 200 milligrams orally once daily.
- 1st-of-its-kind Parkinson’s drug: The FDA approved Juvmo (tavapadon, AbbVie), the first and only selective D1/D5 receptor agonist for adults with the condition. The once-daily tablet can be taken with or without oral levodopa. In the phase 3 TEMPO-3 trial, Juvmo plus levodopa increased daily “on” time without troublesome dyskinesia by 1.7 hours at week 26, compared with 0.6 hours for placebo plus levodopa, and “off” time fell by 1.9 hours compared with 0.9. AbbVie expects it to be available this month.
- 1st-of-its-kind treatment for rare muscle disease: The FDA approved Isembyld (apitegromab, Scholar Rock), the first muscle-targeted therapy for spinal muscular atrophy in adults and children ages 2 and older who are receiving an SMN2-targeted treatment. In the phase 3 SAPPHIRE study, patients on the 10-milligram dose improved 2.2 points more than placebo on motor function at one year, and 34.2% had a gain of at least 3 points, compared with 13.5% on placebo. Fractures occurred in 9% of patients on the 10-milligram dose compared with 2% on placebo.
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