Novo shares high-dose Wegovy results; Amgen, AstraZeneca drugs get expanded OKs
Today, a brief rundown of news involving Novo Nordisk and AstraZeneca, as well as updates from Amgen, Atara Biotherapeutics and Boehringer Ingelheim that you may have missed.
A high-dose form of Novo Nordisk’s obesity drug Wegovy, together with lifestyle intervention, led to greater weight loss over 72 weeks than the current approved dose, according to results from a Phase 3b study. Study participants given a 7.2 milligram dose of Wegovy lost, on average, 20.7% of their body weight, versus 17.5% among those on a 2.4 milligram dose and 2.4% for those on placebo. One-third of people on the high dose achieved greater than 25% weight loss. Detailed results will be presented at a scientific meeting in 2025, while data are expected from a second study of high-dose Wegovy within the next few months. — Ned Pagliarulo
AstraZeneca’s drug Calquence on Friday won Food and Drug Administration approval for adults with previously untreated mantle cell lymphoma who are ineligible for transplant. A rare form of non-Hodgkin lymphoma, MCL is considered aggressive and often leads to relapse. Calquence’s clearance was based on Phase 3 results that showed treatment alongside chemotherapy and Rituxan reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy. Calquence is the first so-called BTK inhibitor approved for first-line treatment of MCL. — Delilah Alvarado
The FDA has approved Amgen‘s KRAS-blocking drug Lumakras for use treating colorectal cancer alongside Vectibix, an older drug sold by the biotechnology company. Use is limited to patients whose tumors express a specific mutation known as KRAS G12C, and who previously received chemotherapy. The FDA based its approval on study data that showed the combination extended progression-free survival by about three-and-a-half months. Lumakras is also approved for non-small cell lung cancer. — Ned Pagliarulo
Atara Biotherapeutics on Thursday said it is weighing a broader range of strategic options after the FDA rejected its experimental drug, Ebvallo, for post-transplant lymphoproliferative disease associated with Epstein-Barr virus. According to Atara, the agency issued a complete response letter for issues at a third-party facility contracted to make Ebvallo. There were no citations related to Ebvallo’s manufacturing process specifically, or its clinical safety or efficacy, Atara said. Together with partner Pierre Fabre Laboratories, Atara submitted Ebvallo, an allogeneic cell therapy, for use in adults and children two years or older who received at least one prior therapy for their disease. Atara is now working with Redmile Group to obtain up to $15 million to fund addressing the rejection and resubmitting Ebvallo. — Delilah Alvarado
An experimental Boehringer Ingelheim drug called iclepertin failed to improve cognition or function in adults with schizophrenia, the company said Thursday. Results from three late-stage trials showed treatment did not meet either the trial’s primary or secondary goals versus placebo after six months. The study program, called CONNEX, enrolled 1,840 people across 41 countries. Full data will be presented at a future medical meeting, Boehringer said. — Ned Pagliarulo
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