Sarepta CEO disputes FDA revenge narrative; Takeda posts long-term data on key Shire drug
→ Sarepta hasn’t been having its best days with the FDA, but the biotech is keen to stay on the agency’s good side. Pushing against a perception that its second Duchenne muscular dystrophy therapy, Vyondys 53, was rejected in an act of regulatory revenge, CEO Doug Ingram had this to say: “To those may believe that the CRL suggest some sort of bias on behalf of the division of neurology towards Sarepta, I would unequivocally and emphatically disagree. Let me reiterate that I remain convinced that we were treated very fairly and professionally by the division of neurology.”
→ Takeda has unveiled new long-term data on Takhzyro, the hereditary angioedema drug acquired from Shire. Data from the Phase III HELP study, involving patients 12 years old or above, suggested that the drug continues to prevent HAE attacks “at a rate similar to that observed in the pivotal HELP Study, in patients who received treatment for a mean duration of 19.7 (0-26.1) months.”
→ AbbVie has submitted an sNDA to the FDA for Imbruvica in combination with rituximab for the first-line treatment of previously untreated patients (70 years old or younger) with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In the Phase III E1912 study showed, the drug improved both PFS and OS compared to rituximab plus chemotherapy.
→ Trans-Pacific biotech Phanes has teamed up with Fosun Kite Biotechnology, the cell therapy joint venture launched by Fosun and Kite Pharma, to boost their CAR-T. Under the agreement, Phanes will provide a collection of humanized antibodies targeting two cancer antigens to arm CAR-T products for solid tumor treatments in China (including Hong Kong SAR, Macau SAR and Taiwan). Phanes is eligible for unspecified upfront and milestones in addition to royalties, while Fosun Kite owns the right of first negotiation for the use of these antibodies outside of China.