Takeda tees up priority review for storied CMV drug from its $62B Shire buyout
One of the Shire drugs that Takeda spotlighted in its $62 billion takeover is getting a speedy look at the FDA.
The drug, maribavir, is being positioned as the first and only treatment for refractory post-transplant cytomegalovirus infection — after a wild 20-year ride that saw it fail studies and get abandoned while other Big Pharma efforts also crashed.
For the Japanese pharma giant, a success here would also bring much-needed validation in a crucial year in which it’s plotting six regulatory filings and expecting four approvals. Two others have already lined up at the FDA in recent months, including TAK-721 for eosinophilic esophagitis and mobocertinib for EGFR Exon20 insertion mutation positive non-small cell lung cancer. A third, the dengue vaccine candidate TAK-003, has been submitted to the EMA.
First synthesized at GlaxoSmithKline, maribavir was initially licensed to rare and infectious disease player ViroPharma, which took it through Phase II before missing the primary endpoint in a Phase III study in 2009 — preventing CMV infections better than placebo in patients receiving bone marrow transplants.
ViroPharma ended up getting bought by Shire for $4.2 billion in 2013, but not before it proposed increasing the dose. Shire ran with the idea, giving 4 to 12 times more drug in various studies, and got the Phase II results they were looking for in 2016, which also earned a breakthrough designation.
The rest is the classic tale of big fish eating medium fish eating small fish.
Takeda spelled out the Phase III data in a presentation earlier this year. Of the 235 patients who received maribavir, 131 (or 55.7%) achieved clearance versus 28 of 117 (or 23.9%) of those on conventional antiviral therapies (p<0.001). Viremia is the isolation of CMV by culture and it’s the primary endpoint of the study.
“CMV is one of the most common viral infections experienced by transplant recipients, and current antiviral treatment options are limited, and physicians have to engage in a careful balance of viral clearance and side effect management that can impact patient care and transplant outcomes,” said Obi Umeh, the program leader for maribavir.