ViewPoints: Zeposia eases regulatory anxiety

Bristol Myers Squibb received an eleventh hour approval for its comeback contender in multiple sclerosis, sending a wave of relief across a sector wary of the FDA's ability to keep the wheels turning as it is impacted by COVID-19.

What happened

Bristol Myers Squibb received its much anticipated approval for Zeposia (ozanimod) to treat multiple sclerosis (MS), checking off another item from the must-execute to do list tied to its buyout of Celgene. The approval marks a successful re-bound from the FDA's refusal of Celgene's filing in 2018- one of a series of clinical development failures that occurred prior to its acquisition by Bristol Myers Squibb.

However, the company only made it partially over the finish line; while it secured the all-important approval, it also said that it will delay its commercialisation plans in the face of the COVID-19 outbreak, and "will partner with the neurology community to inform launch timing."

The launch update follows news from the day prior that Bristol Myers Squibb paused enrolment of new clinical studies, and will not bring new study sites online until at least April 13. Importantly, it also suspended treatment in its cell therapy trials, including idecabtagene vicleucel (ide-cel, formerly known as bb2121) or lisocabtagene maraleucel (liso-cel, formerly known as JCAR017)- with the caveat that enrolment in the registrational trials of the two candidates is already complete, with no expected impact on submission timelines.

The bigger picture

Bristol Myers Squibb will be far from alone in navigating the impact of COVID-19 as the realities of the pandemic settle in across the globe; it joins a growing list of companies that have disclosed modified expectations for their clinical development and commercial plans.

However, the approval news was a welcome sign of normalcy from the FDA. The agency has made statements to emphasise that it still expects to execute on its workload while under travel restrictions and with an increased prioritisation for any COVID-19 matters, while at the same time delaying or cancelling advisory meetings- most recently, Intercept Pharmaceuticals' April 22 meeting to discuss obeticholic acid.

The agency successfully hitting its decision deadline- while dramatically coming in just under the wire- was interpreted as a positive signal that essential systems are still operational. Of course, they'll need to stay that way to support other benchmarks Bristol Myers Squibb laid out in its Celgene merger- including an approval for liso-cel by year-end 2020 and ide-cel in multiple myeloma by March 2021. The company submitted its liso-cel application in February, with a decision due in August. Mizuho's Salim Syed notes that Bristol Myers Squibb technically has until July 31 to submit ide-cel and still meet its own deadline.

Competitor impact

One unexpected beneficiary of the Zeposia regulatory news is Biogen- which will be looking to decrease the impact of the competing MS product on its Tecfidera franchise. This might prove challenging under normal circumstances, as Zeposia's label has some competitive advantages in the MS space. Analysts note that unlike Novartis' Gilenya, Zeposia doesn't require monitoring of patients with administration of the first dose.

There was no price attached to the delayed Zeposia launch, though analysts are benchmarking $92,000 as the median wholesale acquisition cost across MS drugs- though both Tecfidera and Gilenya are now priced at a premium to that benchmark.

But aside from the benefit of the delayed entry for a new competitor, Biogen also now has increased confidence that the FDA will be at the ready to handle its next critical submission- aducanumab to treat Alzheimer's disease. Originally one of the most highly-anticipated catalysts for 2020, interest in the prospects for the amyloid antibody has waned as the sector re-focused on COVID-19. (See ViewPoints: Biogen’s three key points of contention)

Biogen has said that it will make a disclosure when it submits its application, expected for the first quarter. However, all has been quiet on the regulatory front, raising questions about the status of the controversial filing- although the update for Zeposia suggests that the FDA might not be to blame for any ensuing delays to the review package.

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