Pharmaceutical Industry Update: Mixed Results in Clinical Trials and Regulatory Decisions
Bristol Myers Squibb's Reblozyl Falls Short in Myelofibrosis Study
Bristol Myers Squibb announced that its anemia treatment, Reblozyl, failed to meet its primary goal in a Phase 3 study involving patients with myelofibrosis. Despite this setback, the company reported a "numerical and clinically meaningful" improvement in red blood cell transfusion independence among treated patients compared to those receiving placebo.
The pharmaceutical giant remains optimistic about Reblozyl's potential, citing encouraging data from secondary measures. Bristol Myers plans to engage with regulators to discuss the possibility of submitting an approval application for this new indication. Reblozyl is currently approved for treating anemia in certain patients with beta thalassemia and myelodysplastic syndromes.
FDA Advisory Committee Votes Against GSK's Blenrep
In a significant blow to GSK, an FDA advisory committee voted against recommending the return of multiple myeloma drug Blenrep to the U.S. market. The panel concluded that data from two trials failed to demonstrate a favorable benefit-risk balance for the proposed patient population.
Prior to the meeting, FDA staff had raised concerns about Blenrep's dosing and eye toxicity. The antibody-drug conjugate was previously withdrawn from the market in 2022 following the failure of an earlier confirmatory study. The FDA is set to make a final decision on Blenrep's approval by July 23.
Regulatory Updates and Clinical Progress
The FDA has approved a pre-filled syringe formulation of GSK's Shingrix shingles vaccine, streamlining the administration process for healthcare professionals. This approval applies to adults aged 50 and older, as well as immunocompromised individuals aged 18 and older who are at high risk of shingles.
In other developments, DiaMedica Therapeutics reported positive early results from a Phase 2 study of DM199, a potential treatment for preeclampsia. The company plans to expand the trial, enrolling up to 90 women with preeclampsia and 30 with fetal growth restriction.
Executive Changes at PureTech Health
PureTech Health announced the departure of CEO Bharatt Chowrira, following closely on the heels of board chair Raju Kucherlapati's exit. Chief Portfolio Officer Robert Lyne will serve as interim CEO while the company determines its plans for finding a permanent successor. This leadership shake-up comes just over a year after founding CEO Daphne Zohar left to run PureTech-launched Seaport Therapeutics in April 2024.
References
- Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have become more difficult after the negative advisory committee vote.
Explore Further
What are the potential next steps that Bristol Myers Squibb might take regarding Reblozyl after the myelofibrosis study results?
How might the FDA advisory committee's decision against GSK's Blenrep impact future drug approvals related to multiple myeloma treatments?
What is the competitive landscape for anemia treatments that Reblozyl would potentially enter if approved for myelofibrosis?
What are the potential market implications for GSK if the FDA decides against approving Blenrep?
What are the significant factors contributing to the leadership shake-up at PureTech Health, and how might this affect their ongoing projects and partnerships?