Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.H3 Pharma, a Montreal-based pharmaceutical product development company, has received an approvable letter from the FDA for Sanvar IR in the treatment of acute esophageal variceal bleeding secondary to portal hypertension.
Subscribe to our email newsletter
In the letter, the FDA requests additional supportive efficacy data on the product candidate and additional information related to manufacturing aspects of the product. H3 Pharma intends to address the issues raised by the FDA within the first quarter of 2005.
Sanvar IR (vapreotide) was approved by the Mexican Health Authority for this indication as well as four other indications, in August 2004.
“We are very pleased to have received this approvable letter from the FDA,” said Dr Loic Maurel, president and CEO of H3 Pharma. “Following the successful completion of our phase III study in 2000, an additional confirmatory study was performed in Eastern Europe involving 280 patients. This study has just been completed and an analysis of the results will allow us to follow up with the FDA within a short timeframe,” he added.
Sanvar immediate release (IR) formulation is the only somatostatin analog to demonstrate statistically significant benefits in the treatment of esophageal variceal bleeding (EVB) in association with endoscopic therapy in a placebo controlled clinical study. It is also the only somatostatin analog that is stable at room temperature for extended periods of time.
Sanvar has been granted orphan drug status in the US, which will provide seven years market exclusivity for the product, once launched. The global market for somatostatin analogues is expected to reach $1.1 billion this year.
The previous phase III clinical study in France was conducted with 227 patients in 22 centres. Sanvar IR was shown to significantly reduce active bleeding. Survival with hemostasis at five days was achieved significantly more often with Sanvar IR than with placebo.
In patients with control of bleeding at day five, Sanvar IR significantly increased hemostasis and survival through day 42. Sanvar IR could therefore provide important incremental benefits compared to endoscopic treatment alone in achieving hemostasis in patients presenting with acute variceal bleeding.