Novo sinks on obesity drug results; Sanofi reveals anticipated MS data
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Today, a brief rundown of news from Sanofi and Novo Nordisk, as well as updates from The Lasker Foundation, Edgewise Therapeutics and Vanda Pharmaceuticals that you may have missed.
Novo Nordisk shares fell 6% in Friday trading today after reporting mixed study results from a Phase 2 trial of a weight-loss drug it acquired in a deal for startup Inversago Pharma last year. According to Novo, people who received the lowest dose of the drug, a new type of medicine blocking the protein receptor CB1, lost an average of just over 7 kilograms of weight after 16 weeks. Higher doses resulted in “limited additional weight loss,” while drug recipients reported gastrointestinal as well as neuropsychiatric side effects. Novo is planning a larger and longer mid-stage study of the drug, monlunabant, to find the “optimal dosing to balance safety and efficacy,” said Martin Holst Lange, its executive vice president and head of development, in a statement. — Jonathan Gardner
Sanofi on Friday presented study results the company has claimed could support approval of its experimental drug tolebrutinib in a form of multiple sclerosis. The data showed tolebrutinib helped delay the time to onset of confirmed disability progression by 31% compared to a placebo in people with non-relapsing secondary progressive MS, while also inducing a spike in liver enzymes that Sanofi said can be managed by monitoring patients. Overall, the findings should “enable global filings and approvals given [the] current unmet need” in that form of MS, wrote Jefferies analyst Peter Welford. — Ben Fidler
Three scientists whose research led to a new group of widely popular weight-loss drugs have won a Lasker Award, an annual prize given for discoveries that advance medicine and public health. Joel Habener of Massachusetts General Hospital, Svetlana Mosjov of The Rockefeller University and Lotte Bjerre Knudsen of Novo Nordisk were each handed awards for their roles researching and developing the GLP-1 medicines now used to treat diabetes and obesity. The three have “introduced a new era of weight management in which GLP-1 based pharmaceuticals promise to dramatically enhance health,” the Lasker Foundation said in a Thursday statement. — Ben Fidler
Shares of Edgewise Therapeutics surged nearly 50% after the company on Thursday revealed early study results for a drug it’s developing for a form of heart failure. Though only from a small number of healthy volunteers in a Phase 1 trial and people with hypertrophic obstructive cardiomyopathy in a mid-stage study, the data “clearly differentiates” Edgewise’s drug from Bristol Myers Squibb’s Camzyos and Cytokinetics’ aficamten, wrote Leerink Partners analyst Joseph Schwartz. Edgewise dosed the first participants in the next part of its Phase 2 study and expects to report findings next year. — Ben Fidler
The Food and Drug Administration on Thursday declined to approve a Vanda Pharmaceuticals drug called tradipitant for symptoms of gastroparesis. Vanda claimed the agency “generally disregarded the evidence” from two placebo-controlled trials and requested additional studies with a design and duration that are "inconsistent with the advice of key experts" in the field. The company still plans to pursue an approval in gastroparesis, and intends to file a separate application for use preventing vomiting and motion sickness. — Delilah Alvarado
The House Energy and Commerce Committee voted unanimously Wednesday to support legislation extending the pediatric rare disease voucher program for another six years, to 2030. The program, which was due to expire on Sept. 30, grants companies that win approvals of medicines for rare pediatric diseases a voucher that speeds up drug reviews and can be sold for cash. As of the end of April, the FDA had awarded 53 vouchers since the program’s inception in 2012, according to the National Organization for Rare Disorders. — Jonathan Gardner