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Good morning, and thank you for sticking with us ahead of Labor Day weekend. I’ll be visiting Austin for the weekend and would welcome any recommendations!
Now let’s get into the biotech news today, which is all about a big direct-to-consumer push by pharma companies.
The need-to-know this morning
- Vaderis Therapeutics reported that its daily oral treatment reduced nose bleeds in patients with a rare bleeding disorder called HHT.
- We have another immunology/inflammation-focused biotech: Navigator Medicines launched with a $100 million Series A round, co-led by RA Capital Management and Forbion.
Pfizer joins the DTC bandwagon
This morning, Pfizer launched a direct-to-consumer platform called Pfizer for All — an online portal that provides resources on the company’s migraine drugs and connects patients with telehealth providers and an online pharmacy. (The portal will also provide resources related to Covid-19, flu, and certain vaccines.)
Pfizer follows other companies including Amgen, AbbVie, and Eli Lilly in promoting virtual care alongside marketing for their migraine drugs. Critics, however, say this kind of platforms potentially risks directing patients toward substandard care and overprescribing.
Read more from STAT’s Katie Palmer.
Lilly’s DTC portal launches Zepbound vials
Speaking of direct-to-consumer platforms, Eli Lilly will now be offering vials of Zepbound through its portal, called LillyDirect. Patients must have on-label prescriptions for the obesity drug (from any doctor), and they must submit an order for the vials through the portal.
Zepbound suffered severe shortages earlier this year, and selling the drug in vials will likely ease supply constraints and allow Lilly to reach more patients. The company is also selling the vials at a discount to the list price of the pens.
Novo to study long-term Wegovy use in teens
Meanwhile, Novo Nordisk has registered a new clinical trial to study long-term use of its obesity drug Wegovy in teens.
While Wegovy is already approved for adolescents 12 and older, some doctors have been concerned that there’s fairly little data on the safety and efficacy of teens using the drug for many years into adulthood.
In the new study, all participants will receive Wegovy and they’ll be followed for a minimum of three years. The study will primarily track the number of participants who have maintained a BMI below the obesity threshold, but it will also look at the number of people who taper off the medication.
Last year, when the American Academy of Pediatrics released its clinical guidelines on obesity in young people, it recommended that drugs could be considered for those older than 12. That set off a huge debate, with critics saying that the AAP didn’t fully consider long-term implications of the drugs’ use. Read more about that controversy here.
Are we ready for over-the-counter CGMs?
Continuous glucose monitors are about to be dramatically more accessible. Dexcom started to sell a CGM, called Stelo, over-the-counter yesterday, and Abbott has said it plans to release a device, called Lingo, before the end of the summer.
The devices are being targeted at a huge swath of potential users: the nearly 100 million Americans with prediabetes (including the majority who don’t know it), people with type 2 diabetes who don’t use insulin, and even healthy people who want to keep an eye on their blood sugar levels.
But some experts are concerned that OTC access to the devices opens up the risk of misuse and even harm. They recounted stories of users without diabetes who became unhealthily obsessed with controlling their blood sugar while using CGMs.
Correction: Yesterday’s newsletter incorrectly stated that Eli Lilly was involved with MetaBio’s GLP-1 work.
More reads
- Diabetes took over her life, until a stem cell therapy freed her, Washington Post
- Once one of immuno-oncology’s next great hopes, CD47 faces final shots on goal, Endpoints
- FDA widens probe of ccstasy-based drug studies, Wall Street Journal
- WHO launches plan to stanch mpox transmission and says the virus can be stopped, Associated Press
- Opinion: The importance of reducing the financial burden of participating in clinical trials, STAT