Daiichi Sankyo's FLT3 inhibitor overcame FDA rejection to win an approval. Astellas signed another protein degrader deal, this time with PeptiDream. Takeda's enzyme replacement therapy flunked a mid-stage trial in a rare neurological disorder. And more.
1. After FDA snub, Daiichi's Vanflyta gains US approval and tees up AML clash with Novartis, Astellas
About four years after an initial FDA rejection, Daiichi Sankyo has finally won approval for its FLT3 inhibitor quizatinib as a treatment for acute myeloid leukemia. Now marketed as Vanflyta, the Daiichi drug will compete against Astellas’ Xospata and Novartis’ Rydapt. Vanflyta’s label only covers cancers with FLT3-ITD mutations, while its rivals' approvals cover any FLT3 mutations.
2. Astellas notches another protein degrader pact with $21M upfront for PeptiDream
Astellas has put down 3 billion yen ($21 million) up front to tap PeptiDream’s peptide discovery platform to develop protein degraders. PeptiDream will also be in line for potential milestone payments up to 20.6 billion yen ($145 million) per target, plus single-digit percentage sales royalties. Astellas has previously inked protein degrader deals with Cullgen and Fimecs.
3. Takeda suffers setback as promising neuroscience prospect flunks phase 2
Takeda’s TAK-611, an enzyme replacement therapy proposed for the rare genetic disease metachromatic leukodystrophy, has failed in a mid-stage trial. The phase 2 trial didn’t meet primary or secondary endpoints, according to Takeda. The readout was listed as a potential inflection point for Takeda’s late-stage neuroscience programs for this fiscal year.
4. Takeda hypes up dengue vaccine launch progress as Vyvanse generics loom
Takeda is touting the progress of its dengue vaccine Qdenga despite a recent decision to pull its application in the U.S. The company is now focused on some endemic markets, which make up about 80% to 85% of the vaccine’s peak sales projection of $1.6 billion to $2 billion, CEO Christophe Weber said on a confererence call. Takeda is getting closer to having end-to-end in-house production capability for Qdenga by 2025, he said.
5. Lawmakers propose federal database to track supply chain vulnerabilities
Sen. Gary Peters (D-MI), chair of the Homeland Security and Governmental Affairs Committee, has teamed with Republican Sens. James Lankford (R-OK) and Mike Braun (R-IN) to introduce a bill to create a federal database to track supply chain vulnerabilities. The Mapping America’s Pharmaceutical Supply Act would catalog the origin of each drug, quantities available and the location of their manufacturing facilities.
6. Centaur Pharmaceuticals slapped with FDA warning letter outlining quality, cleaning lapses
Centaur Pharmaceuticals’ drug ingredient plant in Maharashtra, India, got an FDA warning letter with two observations about quality deficiencies and lapses in cleaning protocols. The agency is demanding Centaur completely assess its documentation systems and manufacturing standards training program.
Other News of Note
7. AstraZeneca enlists SK Chemicals to produce diabetes combo drug Sidapvia
8. India’s pharma exports continue to rise despite manufacturing scandals, trade body says (Reuters)