Pfizer’s Valneva-partnered Lyme disease vaccine is nearing a regulatory submission, with interest in preventative options against the tick-borne disease rising around the world. But the FDA won’t be its first stop. Rather, Europe will likely become the launching pad for the new highly-anticipated preventive, executives said.
But it won’t be the only market for the vaccine, they emphasized on a third quarter earnings call Tuesday. “Awareness of the disease, of course, in the U.S., it’s skyrocketing right now because we do have an increase of severity and incidence,” CEO Albert Bourla said.
Pfizer confirmed on the call that discussions are ongoing with the FDA about a regulatory submission for PF-07307405 as executives expressed excitement over the ongoing regulatory process for the shot, which was developed in partnership with Valneva. Analysts have suggested that the FDA filing could be completed by the end of the year. An update on regulatory discussions in the U.S. will occur sometime this quarter, according to Chris Boshoff, Pfizer’s chief scientific officer and president of R&D.
As for the European launch, executives declined to pinpoint a timeline but said regulators on the other side of the pond have commenced their review after the European Medicines Agency (EMA) confirmed receipt of Pfizer’s application in August. The Committee for Medicinal Products for Human Use (CHMP), which recommends new medicines for approval in Europe, is set to deliver its verdict in 2027.
Pfizer is calling upon lessons learned from one of the first drugs ever made available on the internet—Viagra—as it commercializes a new obesity drug in China.
Meanwhile, the vaccine has been filed in Canada as well.
Europe is a natural place for Pfizer to start with the Lyme disease vaccine, since Pfizer owns a tick-borne encephalitis (TBE) vaccine portfolio marketed there from a long-ago acquisition, Chief International Commercial Officer Alexandre de Germay said.
“We know how to activate tick-borne populations in those endemic areas because we have a sales force, we have a commercial play with pharmacies, and so we are very excited with the opportunity,” de Germay said.
Lyme is much more known than TBE, which will help with the commercialization strategy, de Germay added.
Source: www.biospace.com
