Ocaliva Gets Complete Response Letter

The U.S. Food and Drug Administration (FDA) was expected to finalize its review for Ocaliva^® (obeticholic acid – Intercept), completing accelerated approval postmarking requirements needed for full approval on or before Oct. 15, 2024; however, on Oct. 17, 2024, its review was extended with no new date provided. On Nov. 12, 2024, the FDA issued a Complete Response Letter (CRL) to Intercept Pharmaceuticals stating it is unable to fully approve Ocaliva. This is in alignment with the Advisory Committee vote that the clinical benefit in primary biliary cholangitis (PBC) remains unclear. Ocaliva will remain available under accelerated approval and Intercept plans to work with the FDA on next steps.

New Nilotinib Formulation Approved with No Mealtime Restriction

On Nov. 14, 2024, Azurity Pharmaceuticals announced a new nilotinib formulation, Danziten^™, was approved by the FDA for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adults with chronic and accelerated phase Ph+ CML resistant to or intolerant to prior therapy that included imatinib. Originally approved in 2007, Tasigna^® (nilotinib – Novartis) is a tyrosine kinase inhibitor (TKI) that carries a boxed warning to avoid food two hours prior and one hour after taking each twice daily capsule as food causes increased absorption and therefore increases the risk of significant prolongation of the QT interval. The new formulation can be taken without regard to food and at a lower dose while showing consistent pharmacokinetics to Tasigna. The recommended dose of Danziten is 142mg or 190mg orally twice daily at about 12-hour intervals with or without food. Cost information is not known at this time; however, it is expected to be launched in the coming weeks. For full prescribing information, look here.

GLP-1/GIP Compounding Market Snapshot Issues Document Many online companies capitalized on customer interest in semaglutide and tirzepatide for weight loss and began offering telehealth prescribing of the compounded versions of these medications at lower prices than the commercial products while they were in shortage. Now that the medications are no longer in shortage, the future of these compounds is in question. The attached document provides details on this issue.