3.229.124.74
dgid:
enl:
npi:0
-Advertisement-
-Advertisement-
FDA Alerts
Hematology
Trending Topics

FDA Grants Breakthrough Designation to Pulmonary Arterial Hypertension Treatment

Posted on April 8, 2020

The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).

“In January of this year, we reported positive topline results from our PULSAR Phase 2 placebo-controlled trial of sotatercept in patients with PAH,” said Habib Dable, President and Chief Executive Officer of Acceleron in a press release. “Based on the results, we believe that sotatercept has the potential to shift the current treatment paradigm and provide significant benefit to patients with PAH on top of currently available therapies. Thus, we’re thrilled that the FDA has granted this Breakthrough Therapy designation—a first for an Acceleron-discovered medicine and for a therapeutic candidate in PAH—as it supports and aligns with our mission to deliver novel therapeutic options to patients in need as quickly as possible.”

Read the full press release here.

Source: Acceleron

-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-