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STAT+: Pharmalittle: We’re reading about copycat weight loss drugs, ADHD prescriptions spiking, and more
The FDA wants to end bulk production of copycat versions of weight loss drugs; telehealth companies and compounding pharmacies have other plans
Top of the morning to you, and a fine one it is, despite the dreary gray skies hovering over the Pharmalot campus. We are doing our best to maintain sunny spirits, though, because once again, we recall some helpful wisdom from the Morning Mayor, who taught us that “every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is maple cinnamon French toast, for those tracking our habits. Feel free to reach for your own cup while you peruse the items of interest assembled below. After all, the neurons can use all the help they can get. On that note, have a lovely day and do keep in touch. We appreciate any and all thoughts and suggestions. …
The U.S. Food and Drug Administration wants bulk production of copycat versions of popular weight-loss drugs to stop, but telehealth companies and compounding pharmacies that have fueled widespread use of the knockoffs have other plans, The Wall Street Journal writes. Hims & Hers Health will keep offering compounded versions of Ozempic and Wegovy tweaked to individual prescriptions. And some pharmacies making the GLP-1 drug copycats will continue. Production of pharmacy-prepared versions of Zepbound were supposed to have stopped on Wednesday, and later in the spring for knockoffs of Ozempic and Wegovy. The firms are seeking to take advantage of current law, which allows compounding pharmacies to make special, individualized versions of drugs that are not available commercially. Telehealth firms and pharmacies instead intend to sell versions of the obesity drugs tailored for specific patients whose doctors say they need a different dosage than one of the original drugs or a version with extra vitamins added.
Six years after the FDA approved Zolgensma, a Novartis gene therapy for spinal muscular atrophy for children under age 2, investigators presented data from a trial in 126 children showing the treatment worked for children between the ages of 2 and 17, STAT reports. It has been a long wait, although the limitation was logical. The pivotal trial used for approval enrolled only babies under 6 months. Two-year-olds born with the most common and severe form of SMA would likely have lost too many neurons to benefit from the therapy. Yet there were many older children and even some adults with debilitating but more mild disease who might be treated. Much has changed, though, since Zolgensma’s earliest trials. In 2016, Ionis won approval for an infusion called Spinraza. After Zolgensma was approved, Roche won approval for a pill. Last year, Scholar Rock announced data for an antibody that targets patient muscles. These medicines have been a godsend, but for physicians, patients, and families, they also created a head-scratcher. Zolgensma is essentially standard of care for newborns, but it is otherwise hard to discern which of the medicines is the best option.
