Today, a brief rundown of news from the Food and Drug Administration and Intellia Therapeutics, as well as updates from United Therapeutics, the Department of Health and Human Services and Merck & Co. that you may have missed.
The Food and Drug Administration issued 30 warning letters to telehealth companies for making “false or misleading claims” about GLP-1 products offered on their websites. The new batch of letters is the second round the agency has sent since September, and warns companies making claims of “sameness” with FDA-approved medicines while obscuring product sourcing. The announcement comes amid a broader crackdown on pharmaceutical ads by the agency and a recent step-up in threats against GLP-1 copycats after Hims & Hers’ short-lived attempt to launch a compounded version of Novo Nordisk’s Wegovy pill.
U.S. regulators on Monday also cleared Intellia Therapeutics to resume a Phase 3 trial evaluating one of its experimental gene editing treatments against transthyretin amyloidosis with cardiomyopathy, a progressive heart condition. The study is one of two late-stage trials that were paused last year following the death of a participant. Both have now been cleared to restart with new safeguards and, in the latest case, updating the study protocol to exclude patients with a recent history of certain heart problems. Intellia shares initially climbed by more than 10% before falling back.
A pulmonary arterial hypertension drug from United Therapeutics lowered the risk of patients’ disease worsening by 55% compared to a placebo in a Phase 3 trial, positioning the company to seek approval later this year. The drug, ralinepag, is a newer type of prostacyclin receptor agonist, a therapy designed to help widen blood vessels in people with the condition. The results “exceeded expectations” and “compare favorably” with what was observed in testing of another prostacyclin therapy, Johnson & Johnson’s Uptravi, wrote Leerink Partners’ Roanna Ruiz. United acquired ralinepag via a 2018 icensing deal with Arena Pharmaceuticals.
Health and Human Services Secretary Robert F. Kennedy Jr. appointed two new members to the key federal panel, ACIP, that guides U.S. vaccine policy. One new appointee is Sean Downing, a Florida-licensed primary care physician who works in concierge medicine. The other is Angelina Farrella, a pediatrician and owner of a medical practice in Webster, Texas. The two have joined a committee that’s been overhauled over the last year and since weakened multiple longstanding vaccine recommendations, drawing criticism from major medical organizations as well as, recently, a lawsuit from 15 Democrat-led states. The panel’s next meeting is scheduled for March 18.
Merck & Co. on Saturday detailed a pair of study results that could help broaden the use of its kidney cancer drug Welireg. In one study, adding Welireg to Merck’s immunotherapy Keytruda after surgery to remove a tumor reduced the risk of disease progression or death by 28% when compared to Keytruda alone. In the other, Welireg and Eisai’s Lenvima cut that same risk by 30% versus Exilixis’ Cabometyx in people who relapsed after treatment with Keytruda. The results, which Merck first announced without specifics last year, position the Welireg regimens to “rapidly become standard-of-care treatments” in their respective settings, wrote Leerink’s Daina Graybosch. The Leerink team is predicting more than $3.4 billion in U.S. peak sales for Welireg, which Merck acquired in a 2019 buyout.
