The Year Ahead in Drugs
Ed Cara has been covering the health and science beat at Gizmodo for five years, which has often included diving deep into important drug approvals and monumental medical breakthroughs. You can send him tips at ed.cara@gizmodo.com.
The top story:
In July 2021, the Food and Drug Administration approved Novo Nordisk’s Wegovy, the first new obesity treatment in nearly a decade. The drug is part of a relatively novel class of medicines called incretins, which mimic the hormones that help regulate our appetite. More than one expert has heralded these drugs as “game-changers” that will revolutionize the field of obesity treatment, with average weight loss results approaching the success seen with surgery. So far, they appear to have lived up to the hype, but not without complications. Novo Nordisk has experienced widespread shortages of Wegovy and Ozempic (a lower dose version of the same active ingredient, though only approved for type 2 diabetes) for the past year and a half. These shortages have led to a slowdown in new and recurring prescriptions, including for patients who have taken Ozempic to manage their diabetes.
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The supply problems are supposed to finally be alleviated this year. But Wegovy will remain a luxury item for many people who want it, since the drug isn’t currently covered by Medicare and many private insurers. Without insurance, it can cost upwards of $1,500 a month.
Another upcoming storyline in 2023 is the emergence of Eli Lilly as a competitor to Novo Nordisk. Phase III results released last year indicate that their drug tirzepatide can provide even greater weight loss on average than Wegovy (over 20% from baseline for those on the highest doses). The drug was approved for type 2 diabetes in May 2022 under the brand name Mounjaro. And with the FDA agreeing to fast track their typical review process for the drug last fall, tirzepatide could win approval as an obesity treatment as soon as late 2023.
Other candidates that have their own advantages over these two are expected to reach the public within the next decade. And with over 40% of adult Americans estimated to be living with obesity, all of these drugs could see widespread use. At the same time, it’s unclear whether any of them will be truly affordable for the foreseeable future.
Unconventional wisdom:
UK-based pharmaceutical company Futura may soon disrupt the world of erectile dysfunction treatment thanks to their over-the-counter topical gel, MED3000—the first product of its kind. In Phase III trial data released last year, the gel appeared to work as quickly as ten minutes after application, with results comparable (if less effective overall) to the lowest dose of tadalafil, the active ingredient of Cialis. Futura plans to market MED3000 as a medical device and expects a FDA decision on its approval by early 2023. With prescription ED drugs like Viagra continuing to earn a billion dollars in annual sales, there seems to be a huge market available for a similar product that could be easily purchased on the go.
What we’re waiting for:
The FDA’s approval decision on Biogen and Essai’s antibody-based drug for Alzheimer’s disease, lecanemab. The drug is the first anti-amyloid treatment to show a clear (if likely modest) benefit in slowing down cognitive decline in Phase III research. But recent reports of at least three people dying after taking the drug might complicate the FDA’s evaluation. Its potential defeat could also represent the last hurrah for supporters of the amyloid hypothesis: the theory that misshapen amyloid beta in the brain is the driving force behind Alzheimer’s, and that targeting amyloid can slow down or reverse its progression.
The start of clinical trials testing pig-to-human organ transplantation. Several research teams in the past year have shown that organs taken from genetically modified pigs can survive the initial journey into a human body without causing acute rejection. But the first living donor to receive a modified pig heart last January died several months later, at least partly due to an infection hidden in the organ that wasn’t caught by researchers. Last summer, the FDA signaled that it would soon allow clinical trials of the technology, though no explicit timeline has been established yet.
Better male birth control. After many false stops, various research teams and organizations appear to be on the brink of making safe, long-lasting, and non-surgical male contraception a reality. Male birth control gels, pills, and implants are actively or soon will be tested in humans. Expect to see plenty of news on this front over the next year.
People to follow:
Mark Cuban: The entrepreneur and reality show judge made a huge splash in the healthcare industry last year with the public launch of his company Cost Plus Drugs, a direct-to-consumer service that provides prescription generic drugs at far lower list prices than usual. These drugs have initially been sold without the possibility of insurance coverage. But in December, the company announced a partnership with EmsanaRx, a pharmacy benefit manager, as part of its new goal to reach people covered through employer plans.
Hugh Auchincloss: The long-tenured public health official was revealed last month as the acting director of the National Institute of Allergy and Infectious Diseases, replacing the well-known Anthony Fauci. The NIH is searching far and wide for a permanent replacement, but Auchincloss could set the agenda for one of the government’s largest funders of biomedical research for quite some time.
Elon Musk: The regularly-beclowned billionaire has had his fingers in many pies over the years, including as one of the founders of the tech company Neuralink. Musk has promised that Neurolink will deliver brain implants and other technology that could revolutionize the field of neuroscience, though these promises haven’t come with any real data to back them up. Neuralink is reportedly planning to conduct human trials this year, though it remains to be seen whether the FDA will approve them and whether Musk and the company will survive allegations of repeated animal welfare violations from its earlier experiments.
Companies to watch:
Pfizer is poised to continue building off its recent successes, with the FDA scheduled to decide on the approval of their RSV vaccine for older adults by May 2023. It may debut up to 10 new products this year as well.
Eli Lilly could establish a firm grip on the obesity medicine field for years to come. Not only is it expected to win approval this year for tirzepatide, but it’s about to launch large clinical trials for another candidate that could be even more effective, along with a pill-based treatment that would be easier for patients to tolerate (these newer obesity drugs are typically delivered via weekly injection).
Arcutis Biotherapeutics scored its first approved drug earlier last summer with a novel and steroid-free topical cream treatment for plaque psoriasis. And late last year, phase III results demonstrated that the cream could also be effective for those with atophic dermatitis, setting the stage for an expanded approval in 2023. The company—founded in 2016—now looks ready to emerge as a major player in eczema treatment, a condition that can affect up to 10% of Americans.
A longshot bet:
The future of FDA-approved psychedelic medicine could be here sooner than later. Clinical trials in recent years have continued to find that talk therapy paired with psychedelic drugs like psilocybin and MDMA can provide substantial mental health relief, even in patients who haven’t responded to other treatments. Last summer, the Intercept revealed government documents indicating that the Biden administration expects approvals of these therapies to arrive within the next two years. Likely to be first on the list? MDMA-assisted therapy for people with post-traumatic stress disorder.
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