Here are the latest stories being discussed in biopharma today:
Lilly’s Zepbound Resolves Sleep Apnea in Obese Patients, Bolstering Case for Label Expansion
Eli Lilly has announced promising results for its drug Zepbound in treating obstructive sleep apnea among obese patients. At the American Diabetes Association scientific sessions, the company shared data from two Phase 3 trials. In one trial (SURMOUNT-OSA 1), 43% of participants not using PAP therapy experienced disease resolution at the highest dose. In the second trial (SURMOUNT-OSA 2) involving patients using PAP therapy, 51.5% achieved similar results. ‘These results significantly boost our confidence that Zepbound can be an effective treatment for people with moderate to severe obstructive sleep apnea and obesity,’ said Mathijs Bunck, Lilly’s associate VP of medical development.
Bristol Myers Wins Approval for KRAS Drug Krazati in Colorectal Cancer
Bristol Myers Squibb has received accelerated approval for its KRAS inhibitor Krazati for use in colorectal cancer patients. Krazati can now be used alongside Eli Lilly’s Erbitux (cetuximab) for certain locally advanced or metastatic patients who have been previously treated and carry a KRAS G12C mutation. These patients often face poor outcomes and limited treatment options. This drug works by targeting the KRAS protein, locking it in the ‘off’ mode to prevent uncontrolled tumor cell growth.
FDA Director Peter Marks Personally Approves Sarepta’s Gene Therapy, Raising Questions
The FDA has broadened the use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, Elevyedys, to include patients aged four and older. This decision, expected to expand treatment to 80% of patients with the disease, was singularly approved by CBER Director Peter Marks, who overruled his own staff. This move has raised questions about whether this sets a new precedent for how the FDA will handle approvals for treatments targeting devastating diseases with limited options.
Three of Vertex’s Islet Cell Therapy Patients Achieve Insulin Independence
Vertex Pharmaceuticals announced that a third patient in its ongoing Phase 1/2 trial has become fully insulin-independent for over a year via its islet cell therapy, VX-880, for type 1 diabetes. Previously, two patients had also met this milestone. At the American Diabetes Association’s Scientific Sessions, Vertex presented data from 12 patients who received a single infusion of VX-880, showing that 11 of them have either reduced or entirely ceased insulin use, meeting recommended HbA1c levels.
FDA Issues Two Form 483s to Dr. Reddy’s Laboratories for Sites in India
Dr. Reddy’s Laboratories has received two FDA Form 483 notices for two facilities in Andhra Pradesh, India, following inspections in May and June. This brings the total to at least seven Form 483s issued to the company over the past year. Despite the notices, a spokesperson from Dr. Reddy’s emphasized that none of their plants are currently under Official Action Indicated (OAI), Warning Letter (WL), or any other form of escalation and maintain a state of compliance.
US, EU Commit Over $2 Billion to Boost Vaccine Manufacturing in Africa
In efforts to enhance vaccine manufacturing capabilities in Africa, the United States and the European Union have pledged more than $2 billion. This investment aims to foster local production and alleviate reliance on external vaccine supplies, marking a critical step in bolstering health security and preparedness across the continent.
Gilead’s Injection Prevents HIV in Phase 3 Study with Cisgender Women
In a significant development, Gilead Sciences announced that its twice-a-year injection has effectively prevented HIV in a Phase 3 study involving cisgender women. This advancement holds promise for the future of HIV prevention, providing a long-lasting and convenient option for those at risk.
PhRMA Petitions FDA to Reject Colorado’s Drug Import Program
The Pharmaceutical Research and Manufacturers of America (PhRMA) is urging the FDA to dismiss Colorado’s proposed drug import program, arguing that the state has not sufficiently demonstrated cost-saving benefits for consumers. PhRMA alleges that Colorado relies on data from Quebec, while its actual importer is based in Ontario. This development is part of a broader trend as multiple states explore drug import programs to reduce medication costs.