Excitement Over New Migraine Drug; Cost Concerns Over One For Obesity
Fox News reports on "paradigm shift" excitement over a new drug, rimegepant, that blocks migraine attacks. NPR notes that an effective new obesity drug, Wegovy, is raising questions over whether insurers will cover its over $1,000 monthly cost.
First Migraine Drug To Both Block, Tackle Headaches ‘Shifts Paradigm’ Of Treatment
Most of Lilly Rockwell’s earliest childhood memories are plagued with severe headaches to the point of vomiting. Her migraine disease worsened into adulthood as she worried over the impact it would have on her career and personal life. Rockwell, 37, of Austin, Texas, joined her mother in a clinical trial for Biohaven’s Nurtec ODT (rimegepant) as a preventive migraine treatment. The dissolvable tablet won expanded FDA approval on May 27 for the first dual indication as an acute and preventive migraine treatment. Biohaven's findings for its late-stage trial of rimegepant, a calcitonin gene-related peptide receptor antagonist, were published in The Lancet, and according to a company release, the drug dropped migraine days by 30% after a week when taken every other day while about half of participants saw at least a 50% decline in moderate-to-severe migraine days at three months. The drug works by blocking a receptor associated with the cause of migraines. (Rivas, 7/3)
Wegovy's Promise As An Effective Treatment For Obesity Now Depends On Insurers
When a promising new drug to treat obesity was approved by the Food and Drug Administration for sale in the U.S. last month, it was the first such treatment to gain approval since 2014. In clinical trials, weekly injections of semaglutide — or Wegovy, as it's been branded -- helped people drop an average of 15% of their body weight. That's an average of about 34 pounds over 16 months, before their weight plateaued, a far greater weight loss, obesity specialists say, than achieved with other drugs on the market. At least as important, Wegovy raised none of the alarm bells with the FDA or obesity doctors that it might trigger serious side effects of the sort experienced by some people taking fen-phen or some previous medical treatments for obesity. (Noguchi, 7/6)
The New York Times:
Juul Is Fighting To Keep Its E-Cigarettes On The U.S. Market
Sales have plunged by $500 million. The work force has been cut by three-quarters. Operations in 14 countries have been abandoned. Many state and local lobbying campaigns have been shut down. Juul Labs, the once high-flying e-cigarette company that became a public health villain to many people over its role in the teenage vaping surge, has been operating as a shadow of its former self, spending the pandemic largely out of the public eye in what it calls “reset” mode. Now its very survival is at stake as it mounts an all-out campaign to persuade the Food and Drug Administration to allow it to continue to sell its products in the United States. (Kaplan, 7/5)
In biotech news —
Smart Foam Material Gives Robotic Hand The Ability To Self-Repair
Singapore researchers have developed a smart foam material that allows robots to sense nearby objects, and repairs itself when damaged, just like human skin. Artificially innervated foam, or AiFoam, is a highly elastic polymer created by mixing fluoropolymer with a compound that lowers surface tension. (Teo and Shan, 7/6)
If Apple Takes On Fall-Prevention, Will The Rest Of The Health System Hear It?
Using troves of data from iPhone users, Apple thinks it’s cracked an elusive problem: Identifying when older people are on the cusp of a devastating fall injury. Later this year, the iPhone will begin tracking a new metric called Walking Steadiness, and will use it to warn users that may fall. The feature targets a tremendous and often overlooked problem for older adults, accounting for some 3 million emergency room visits each year. But it remains an open question whether such information and loose guidance about what to do with it will prevent falls without robust links to the health care system. (Aguilar, 7/6)
And the controversy over a new Alzheimer's drug continues to swirl —
Is Alzheimer's Association Really Pushing Biogen To Lower Aduhelm’s Price?
The Alzheimer’s Association stunned Washington last month when it urged Biogen to lower the price of it’s new Alzheimer’s drug — an extremely rare rebuke on drug pricing from a patient advocacy group, most of which normally sidestep the topic. (Florko, 7/6)
Physicians Will Feel Pressure As Gatekeepers Of Aduhelm
The FDA's approval of Alzheimer's treatment Aduhelm puts physicians in a difficult position: They hold the prescribing power over a drug that most say is unproven. But desperate patients and families may not know or care about the lack of evidence and will want the prescription anyway. What they're saying: "The public message has to be clear: This is not a cure, and it's not even clear this is going to make substantial changes to someone's disease course," said Sharon Brangman, an Alzheimer's expert and geriatrician at Upstate University Hospital in New York. (Herman, 7/6)
The Washington Post:
The Controversial Approval Of An Alzheimer’s Drug Reignites The Battle Over The Underlying Cause Of The Disease
Neurologist Matthew S. Schrag was surprised when he heard the Food and Drug Administration had approved a controversial Alzheimer’s drug. There was scant evidence the treatment worked, in his view. Even more concerning to Schrag: the FDA’s apparent embrace of a long-debated theory about Alzheimer’s disease, which afflicts more than 6 million Americans. The amyloid hypothesis, which has dominated the field for decades, holds that toxic clumps in the brain, called amyloid beta, are the main driver of the disease and that removing them will slow cognitive decline. (McGinley, 7/5)
Paying Billions For Controversial Alzheimer’s Drug? How About Funding This Instead?
If you could invest $56 billion each year in improving health care for older adults, how would you spend it? On a hugely expensive medication with questionable efficacy — or something else? This isn’t an abstract question. Aduhelm, a new Alzheimer’s drug approved by the Food and Drug Administration last month, could be prescribed to 1 million to 2 million patients a year, even if conservative criteria were used, according to Biogen and Eisai, the companies behind the drug. (Graham, 7/6)