While Novo Nordisk struggles with manufacturing concerns and patient coverage on its long-acting insulin Levemir, Bayer missed a primary endpoint in a confirmatory trial for its PI3K inhibitor Aliqopa. Now, both companies are opting to pull their products from the market.
First up is Novo, which made the call on Levemir after “careful consideration,” citing global manufacturing issues, decreasing patient coverage and the availability of other options for patients to chose from, it said in a discontinuation notice.
The drug, which was originally approved all the way back in 2005, will likely face supply disruption of its pre-filled FlexPen in mid-January 2024 before discontinuation April 1. Meanwhile, Levemir vials will wrap up by the end of next year.
Earlier this year, Novo opted to slash Levemir’s price point by 65%, a move which was to go in effect come Jan. 1. The company also sliced the cost of its NovoLog insulin by 75% and matched Levemir’s 65% for its Novolin.
Meanwhile, Bayer’s Aliqopa was required to show proof of benefit through a confirmatory trial after securing FDA accelerated approval in 2017 for relapsed follicular lymphoma in patients who have received at least two prior systemic therapies.
While full data from the phase 3 CHRONOS-4 study in relapsed indolent non-Hodgkin lymphoma have yet to be revealed, a Bayer spokesperson confirmed in an emailed statement to Fierce Pharma that the trial missed its primary endpoint.
After offering the FDA a voluntary withdrawal, the company is now exploring access options for patients currently receiving the therapy with no suitable alternative treatments, the spokesperson added, noting that the withdrawal will not have a “relevant financial impact” on Bayer.
Aliqopa’s original approval was based on a single-arm phase 2 study. Last year, the FDA flagged PI3K nods based on single-arm studies after six randomized trials suggested that four marketed drugs in the class might shorten blood cancer patients’ life expectancy due to their toxicity. The agency determined that future approvals should instead require randomized clinical trials with active comparators, which an advisory committee later backed.
Bayer’s drug won’t be the first PI3K to flee the market after the FDA spotlight. Gilead Sciences and Incyte have pulled their drugs or scrapped filing plans, while the agency snatched back its approval for TG Therapeutics’ Ukoniq. Bayer also in 2021 withdrew its application for Aliqopa in non-Hodgkin lymphoma.