Optum Rx Highlights Three Pipeline Drugs Set for FDA Review

The pharmaceutical landscape is poised for potential shifts as three significant drugs targeting chronic conditions approach Food and Drug Administration (FDA) review by year's end. A new report from Optum Rx sheds light on why these therapies are capturing the attention of payers and industry watchers alike.

Oral Wegovy: A New Frontier in Weight Loss Medication

Novo Nordisk's oral formulation of Wegovy stands at the forefront of this trio, potentially becoming the first oral GLP-1 approved for weight loss. This development could mark a significant milestone in the treatment of obesity, a condition that has become a major cost driver for healthcare payers and plan sponsors.

The oral version of Wegovy has demonstrated efficacy and safety profiles similar to its injectable counterpart. With a wholesale acquisition cost for injectable Wegovy at approximately $16,000 annually, the pricing for the oral formulation is expected to align with this figure. Sara Guidry, senior director of pipeline and drug surveillance at Optum Rx, notes that while a surge in new users isn't necessarily expected, payers should prepare for potential shifts in utilization from existing products.

Importantly, Wegovy is also under investigation for its potential to reduce the risk of serious cardiac health events, broadening its possible applications and market impact.

Depemokimab: Addressing Eosinophilic Asthma with Less Frequent Dosing

GSK's depemokimab is poised to enter the market for eosinophilic asthma, a rare subtype of the chronic lung disease. What sets this therapy apart is its dosing regimen: administered in-clinic every six months, compared to the more frequent four to six-week injections required by current market leaders such as Dupixent and Nucala.

"That's where depemokimab goes back to that theme of the new dosing option, so it could reduce injection burden for patients," Guidry explains. The FDA's decision on depemokimab is anticipated in mid-December, potentially offering patients a less frequent treatment option in this space.

Rhapsido: An Oral Option for Chronic Spontaneous Urticaria

Novartis's Rhapsido (remibrutinib) secured FDA approval on September 30, introducing an oral formulation to a market segment dominated by injectables for the treatment of chronic spontaneous urticaria (CSU). This condition, affecting approximately 1.7 million people in the U.S., causes repeated, spontaneous hives and skin swelling lasting at least six weeks.

Rhapsido will compete with established treatments like Dupixent and Xolair. While the oral administration may be preferable for some patients, transitioning from over-the-counter antihistamines to a daily oral medication, others may still opt for less frequent injectable treatments.

As the pharmaceutical industry continues to evolve, these three drugs represent significant advancements in the treatment of chronic conditions. Their potential approval and market entry could reshape treatment paradigms and impact healthcare costs, making them crucial developments for payers, providers, and patients to monitor in the coming months.