FDA requests additional time for Flexion's sNDA; Genentech releases data for PhIII study of Rituxan
→ In 2017, the FDA greenlighted Flexion Therapeutics‘ intra-articular therapy, Zilretta, designed as a treatment for osteoarthritis-related knee pain. Now, two years later, the company has announced that the FDA needs additional time to complete the review of its supplemental NDA for Zilretta. The anticipated PDUFA date was set for today. Although the FDA has not provided a new action date, Flexion says they were informed that the review should be completed in the coming weeks. No additional clinical data has been requested by the FDA.
→ Genentech has released data from its Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan (rituximab) compared to mycophenolate mofetil (MMF), in adults with moderate to severe pemphigus vulgaris (PV). The data showed superior results in patients given Rituxan, with 40.3% of patients treated with Rituxan achieving sustained complete remission without the use of steroids for 16 consecutive weeks or more, compared to 9.5% in the MMF arm (p<0.0001). The studies primary endpoint was reached at week 52.
→ Johnson & Johnson‘s drug Xarelto (rivaroxaban) has been approved by the FDA for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalized, acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding. The approval comes a few months after J&J and Bayer paid out $775 million to thousands of Xarelto patients after a 5-year long legal war — the companies were accused of failing to warn patients properly of the bleeding risk associated with the blood thinner.
→ Ultragenyx Pharmaceutical has announced that the FDA has accepted their NDA for UX007 (triheptanoin) for the treatment of long-chain fatty acid oxidation disorders. The PDUFA is set for July 31, 2020.
→ AstraZeneca, Pfizer and Takeda have come together for a collaboration deal with ImaginAb, agreeing to guide a clinical trial for the imaging player in exchange for early access to the data. The study is aimed at assessing the utility and value of ImaginAb’s ImmunoPET technology, which uses mini antibodies and tags CD8+ T cells with radioisotopes to render immune activity visible in a PET scan.
“One of our key objectives is to streamline the clinical development of next-generation cancer immunotherapies so that ultimately cancer patients have access to the best possible treatments,” CEO Ian Wilson said in a statement. “We believe that working with global leaders in immuno-oncology will help us further develop CD8 ImmunoPET as a pharmacodynamic marker for use in drug development and, in the future, as a diagnostic and predictive test for use in hospitals.”