Drug Approvals

Obesity Management Targets Complex Disease via New Drugs, Better Awareness

Despite significant medical advances in the U.S. on numerous fronts, obesity management seems stalled by many clinicians’ reliance on a regimen of “diet and exercise” alone to treat as well as prevent. Obesity medicine specialists cite the increasing availability of safe and effective anti-obesity medications on the market — with dozens more in the pipeline — to allow for a multipronged treatment approach, but they point out that physicians seldom prescribe such drugs, and insurers often balk at paying for them.

This is partly because individuals with obesity, an increasingly prevalent, serious and costly disease, continue to confront the societal bias that “lifestyle choices” are to blame, experts say. It is also because obesity is a complex disease to treat, not merely a matter of gauging body mass index (BMI), they explain, and unless treated effectively, it may become the pathway to a wide array of chronic conditions including heart disease, stroke, type 2 diabetes, asthma and some types of cancer, as well as disability and premature death.

New FDA Appointee Is Likely to Emphasize Real-World Data

President Joe Biden recently nominated former FDA Commissioner Robert Califf, M.D., to run the agency once more, ending nearly a year of temporary leadership under Acting Commissioner Janet Woodcock, M.D. One insider says that Califf might look to reform and improve the accelerated approval pathway following the controversial Aduhelm (aducanumab) approval earlier this year.

Califf previously led the FDA during the Obama administration, running the agency for roughly the last two years of Obama’s term. Califf advocates for using “real-world evidence” in addition to clinical trial data in medical approvals. Aduhelm, an Alzheimer’s drug, was approved without such data, though studies of the drug relying on real-world evidence — which takes into account electronic medical record and insurance claims data — are underway. During Califf’s initial tenure, Sarepta Therapeutics’ eteplirsen, a muscular dystrophy drug, also earned accelerated approval despite a large outcry from medical researchers.

New FDA Appointee Is Likely to Emphasize Real-World Data

President Joe Biden recently nominated former FDA Commissioner Robert Califf, M.D., to run the agency once more, ending nearly a year of temporary leadership under Acting Commissioner Janet Woodcock, M.D. One insider says that Califf might look to reform and improve the accelerated approval pathway following the controversial Aduhelm (aducanumab) approval earlier this year.

Califf previously led the FDA during the Obama administration, running the agency for roughly the last two years of Obama’s term. Califf advocates for using “real-world evidence” in addition to clinical trial data in medical approvals. Aduhelm, an Alzheimer’s drug, was approved without such data, though studies of the drug relying on real-world evidence — which takes into account electronic medical record and insurance claims data — are underway. During Califf’s initial tenure, Sarepta Therapeutics’ eteplirsen, a muscular dystrophy drug, also earned accelerated approval despite a large outcry from medical researchers.

Eli Lilly Pounces on Flailing Aduhelm With Competing Drug

Eli Lilly & Co. has announced plans to run a head-to-head clinical trial of its Alzheimer’s drug, donanemab, against Aduhelm (aducanumab), the controversial Biogen Inc. Alzheimer’s drug. Meanwhile, Aduhelm has continued to have what one expert calls “the worst drug launch ever,” after state Medicaid leaders told CMS they want no part of paying for the drug.

In its third-quarter results, Biogen reported in a Securities and Exchange Commission filing that Aduhelm revenues totaled $300,000, citing the fact that many clinicians don’t want to prescribe the drug. Meanwhile, Eli Lilly & Co.’s donanemab is under an accelerated approval process. That process will include a Phase III study comparing donanemab directly to Aduhelm, according to Daniel Skovronsky, M.D., Ph.D., a Lilly senior vice president and its chief scientific and medical officer.

New FDA Approvals: FDA Grants Additional Approval to Verzenio | Nov. 16, 2021

Oct. 13: The FDA expanded the indication of Eli Lilly and Co.’s Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ­>20% as determined by an FDA-approved test. The tablet is the only CDK4/6 inhibitor approved for this indication. The FDA initially approved the drug on Sept. 28, 2017. Recommended dosing for this use is 150 mg twice daily. The monthly list price is $13,058.08.