GLP-1
Eli Lilly’s retatrutide could present a “differentiated option” for patients with type 2 diabetes who want to control their blood sugar and achieve maximal weight loss, according to analysts at BMO Capital Markets.
Heath Secretary Robert F. Kennedy Jr.’s efforts to overhaul vaccine policy are likely illegal, a Massachusetts District Court Judge ruled; Structure’s GLP-1 weight loss pill succeeds in Phase 2 while Rhythm’s Phase 3 basket trial fails to find the beat; Eli Lilly warns of potential safety risks of taking compounded tirzepatide, and Novo Nordisk is hit with an FDA warning letter regarding adverse events potentially linked to Ozempic.
Structure Therapeutics’ oral obesity drug elicited a placebo-adjusted weight loss of 16.3% at 44 weeks in a Phase 2 trial. The biotech is planning to launch a late-stage program for the drug later this year.
Combining tirzepatide with vitamin B12, a common additive in compounded versions of the drug, yields an impurity that could alter the drug’s toxicity profile and pose safety risks to patients, the company said in an open letter.
Orforglipron, Eli Lilly’s oral obesity drug, is under FDA review with a decision expected in April. The pharma has also filed for marketing authorization for the pill in China.
Among the unreported adverse events potentially linked to Ozempic are two deaths and one case of “completed suicide,” according to an FDA inspection report.
Rare disease biotech stocks pop on the news that Vinay Prasad, the FDA’s chief biologics regulator, will depart the FDA at the end of April; Sen. Ron Johnson launches an investigation into recent rare disease drug rejections; and Roche and Zealand’s amylin analog fails to match investor expectations—and Eli Lilly’s rival candidate—in a mid-stage trial.
The companies have been embroiled in a row about compounded GLP-1 drugs that escalated to a lawsuit last month. The legal action has now been dropped and the former adversaries have struck a deal that could increase access to Novo’s obesity medicines.
Hansoh’s olatorepatide achieved 19% weight loss at 48 weeks in a Phase 3 trial in China, handing partner Regeneron a glimmer of hope for a pipeline in desperate need of reinvigoration.
UniQure and REGENXBIO are both dealing with FDA setbacks for their respective gene therapies, as regulatory experts question the FDA’s decision-making processes; CBER director Vinay Prasad is under probe for allegedly fostering a toxic workplace; Sarepta CEO Doug Ingram is stepping down after several years of tumult at the top of the muscular dystrophy–focused company; and Eli Lilly again tops Novo Nordisk in a weight loss trial.
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