Debiopharm Submits Response to FDA for Haemorrhage Drug
Debiopharm Group, a biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates, has announced that Debiovision Inc, its Canadian affiliate, has filed its complete response to the approvable letter received from the FDA for Sanvar, or Debio 8609.
The immediate release formulation of Sanvar, a somatostatin analogue, is used in the treatment of acute esophageal variceal bleeding. It is used prior to endoscopic intervention to control haemorrhage and prevent re-bleeding during the critical five days following the onset of bleeding.
Debiopharm has already signed license agreements for the sale and marketing of Sanvar, with several commercial partners that include Salix Pharmaceuticals in the US, Ranbaxy Laboratories in India, EMS Sigma Farma in Brazil, LG Life Sciences in Korea, Tzamal Bio-Pharma in Israel, and Medical Futures in Canada.
Rolland-Yves Mauvernay, president and founder of Debiopharm Group, said: “This is an important step towards completing the US registration of our drug. Sanvar has demonstrated therapeutic benefit in the control of acute variceal bleeding prior to endoscopic treatment, an indication for which, to this day, no product has been approved by the FDA.”