Protocols

FDA pins another ‘breakthrough’ badge on AbbVie’s venetoclax; Express Scripts bats back at drugmakers on pricing

AbbVie $ABBV has collected a fifth breakthrough therapy designation for venetoclax as it climbs the blockbuster mountain with the apoptosis drug. The latest endorsement from the FDA covers venetoclax’s first-line use, in combination with obinutuzumab, in chronic lymphocytic leukemia. Having just filed its sNDA, the company is expected to benefit from an expedited review soon.

→ Last week, various high profile, global drugmakers placed the blame for high out-of-pocket patient costs in the United States on the middlemen — pharmacy benefit managers — asserting that they are forced to hike the prices of prescription drugs in response to higher rebates that all-powerful PBMs negotiate at a hearing with US lawmakers. On Wednesday, the largest US PBM — Express Scripts $ESRX — shot back, suggesting the power to lower drug prices ultimately lies with the manufacturers. “We often have asked drug companies to simply lower their prices. Instead, drug companies have elected to increase prices and increase rebates. This is the option drug makers have chosen for themselves and for the marketplace,” the company said in a statement, praising Lilly’s $LLY decision earlier this week to release an authorized generic of its blockbuster Humalog insulin, carrying a 50% discount to the branded version. “We are in discussions with Eli Lilly about Humalog authorized alternative, and if the net cost is lowest for plans, we will add it to our Flex Formulary.”

Biogen $BIIB and Eisai are expecting the final readout for their controversial Alzheimer’s drug BAN2401 in 2022, the partners disclosed today as they mapped a timeline for the confirmatory Phase III study. Sure to be closely watched after some sketchy trial details marred the positive Phase II data, the pivotal study will test the drug in early Alzheimer’s disease patients, though Eisai said it’s exploring a potential Phase III involving patients with amyloid pathology in even earlier stages of the disease.

→ Less than three months into Athenex’s licensing and partnership pact with Chongqing Jingdong, the Buffalo, NY-based biotech $ATNX has decided to pull out and commercialize KX2-391 in China on its own. An experimental drug that Athenex says has passed muster in Phase III, KX2-391 is an ointment designed for actinic keratosis and oncology indications. Athenex gave no explanation for the termination, saying only that it believes the move is “well positioned to align our development strategies in mainland China.”


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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Associate Director CMC
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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