Bayer has purchased the exclusive license to commercialize BridgeBio's potential heart disease blockbuster in Europe, as the drug awaits the green light from regulators.
The drug, acoramidis, is an investigational oral small molecule stabilizer of transthyretin designed to treat transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). ATTR-CM is a rare and fatal condition leading to heart failure, with a high fatality rate within four years of diagnosis.
Per the deal, Bayer will pay BridgeBio up to $310 million comprising of upfront and near-term milestone payments, as well as additional sales milestones and royalties.
The EMA has accepted BridgeBio’s MAA for acoramidis with potential EU approval in 2025. The U.S. FDA has accepted the NDA for acoramidis with a PDUFA action date of November 29, 2024.
Back in February, BridgeBio and its partner in Japan, AstraZeneca's Alexion, shared encouraging outcomes from the Japan trial of acoramidis. In the phase 3 trial, the drug met the defined success criterion of a greater estimated survival probability at 30 months compared to the placebo. The results mirrored those of the global ATTRibute-CM phase 3 trial, which showcased improved survival rates, reduced cardiac-related hospitalizations, and enhanced functional measures at 30 months.
If approved, acoramidis will go up against Pfizer’s similarly acting blockbuster, Vyndaqel, which became the first FDA-approved treatment for ATTR-CM in May 2019.
