Sanvar is a synthetic octapeptide whose international non proprietary name is vapreotide. Sanvar is the only somatostatin analog to have demonstrated success versus placebo in the early treatment of acute Esophageal Variceal Bleeding (EVB) caused by portal hypertension. In the United States, Sanvar has been submitted for registration in the treatment of EVB. The FDA had previously granted Sanvar orphan-drug status and has issued an approvable letter for the drug. Sanvar is registered under the trademark of Docrised in Mexico for the treatment of EVB as well as acromegaly, neuroendocrine tumors, AIDS-related diarrhea and the adjuvant treatment of gastrointestinal fistulas. Debiovision is planning to sign agreements all over the world, and will seek earlier market entry in non-core countries with partners who have regulatory expertise in these regions.

Esophageal Variceal Bleeding Indication

The early administration of Sanvar in Esophageal Variceal Bleeding (EVB) emergencies significantly controls acute bleeding and has a direct effect on patient survival during the critical days following acute hemorrhage. The number of cases of esophageal bleeding is expected at 750,000 cases per year. This number is expected to increase, mainly because it is a late but frequent complication of cirrhosis induced by the current epidemic of hepatitis C infection. Esophageal Variceal Bleeding is an intricate medical emergency with a high mortality rate. In managing this condition, particular care must be taken to restore blood volume, prevent ischemia of the liver and other organs, sustain cardiorespiratory function and prevent severe complications like aspiration, sepsis, renal failure and portosystemic encephalopathy.