Editors' (re)View: Incyte stays busy; A generic IRA perspective

Incyte stays busy

Incyte made headlines this week with two key developments that could shake up treatment options for hard-to-treat diseases.

Yesterday, the FDA approved Niktimvo, a drug developed with Syndax Pharmaceuticals, for chronic graft-versus-host disease (GVHD) in patients who haven’t responded to other treatments.

Niktimvo is designed to tackle the inflammation and fibrosis that come with chronic GVHD, offering a new option where others have fallen short. The approval follows the AGAVE-201 study, which showed that 75% of patients saw positive results within six months, with 60% maintaining those improvements for a year.

Also this week, Incyte reported positive results from its phase 3 inMIND trial, which tested tafasitamab (Monjuvi) for relapsed or refractory follicular lymphoma. The trial met its main goal of improving progression-free survival, meaning patients had more time before their disease progressed. These findings suggest that adding tafasitamab to the standard treatment could provide a significant benefit for those battling this type of lymphoma.

These developments are a step forward for patients dealing with chronic GVHD and follicular lymphoma, conditions where treatment options can be limited.

With the FDA’s approval, Niktimvo is set to hit the U.S. market by early 2025, and Incyte is planning to offer smaller vial sizes to make dosing more efficient. Meanwhile, the positive inMIND results could pave the way for expanding the use of tafasitamab, with a filing expected by the end of the year.

Incyte’s latest moves show a focused effort to bring new treatments to patients who need them, offering fresh hope for those with few alternatives. — Andrea Corona

A generic perspective on the IRA

This week, the Centers for Medicare & Medicaid Services (CMS) unveiled the list of negotiated prices for the first 10 drugs covered under Medicare Part D based on agreements reached between CMS and drug companies.

Passed into law in 2022, the IRA states that drug manufacturers must pay a rebate to the federal government if the prices of certain drugs covered under Medicare Part B and most drugs under Part D rise at a rate that exceeds inflation. The law requires the secretary of HHS to negotiate prices with drug companies for a select number of single-source branded drugs or biologics. Importantly, it excludes drugs that have a generic or biosimilar available from the negotiation process.

But the Association for Accessible Medicine raised an important point following the announcement about the first ten drugs: The government may be solving the wrong problem. 

According to AAM, generic and biosimilar competition is the best way to deliver low-cost drugs for patients and taxpayers, which brings up an important question: Why is it that these drugs don’t have generic competition? The majority of the first ten drugs selected have been on the market at least a decade. Some, like Amgen’s Enbrel, date back to the '90s. Enbrel even has an approved biosimilar from Sandoz that got the green light in 2016 but a federal court decision will keep it off the market until 2029.

AAM called on policymakers to address patent thickets, PBM brand drug rebates and other root causes that delay generic and biosimilar competition, rather than doubling down on government price setting. I don’t think AAM is going to change the government’s mind, but it’s a point well-made. —Karen Langhauser