LIAN - Bristol Myers LianBio's heart drug Camzyos gets priority review in China

2023-04-21 09:09:00 ET

China's National Medical Products Administration (NMPA) granted priority review to Bristol Myers Squibb ( NYSE: BMY ) and  LianBio's ( NASDAQ: LIAN ) drug Camzyos (mavacamten) to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults.

Hypertrophic cardiomyopathy is a condition in which the heart muscle becomes abnormally thick which can make it harder for the heart to pump blood.

LianBio said the NMPA accepted a new drug application (NDA), which was backed by data from a global phase 3 trial called EXPLORER-HCM and phase 1 pharmacokinetic study in healthy Chinese people.

"Gaining alignment with the NMPA to file the NDA prior to the completion of our ongoing Phase 3 trial in China speaks to the strength of the clinical data that has been generated and to our commitment to accelerate patient access to critical new treatments," said LianBio CEO Yizhe Wang.

Mavacamten, is approved in the U.S. under the name Camzyos. The U.S. FDA is also expected to make a decision by June 16 on an application seeking expanded use of the drug based on data from a phase 3 trial called VALOR-HCM.

LIAN +6.13% to $2.25 premarket April 21

For further details see: