Advertisement Pendopharm gets Health Canada approval for hepatitis C drug Ibavyr - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Pendopharm gets Health Canada approval for hepatitis C drug Ibavyr

Pendopharm, a division of Pharmascience, has secured Health Canada approval and market availability of IBAVYR (ribavirin tablets), the first stand-alone oral ribavirin for the treatment of chronic hepatitis C virus (HCV) infections in Canada.

The drug is approved for use in combination with other agents, and will enable some patients to receive an all-oral therapy (without interferon injections), which represents a novel treatment approach in the country.

University Of British Columbia clinical associate professor of Medicine, Division of Gastroenterology Alnoor Ramji said the approval of IBAVYR transforms the treatment of HCV as some patients will now be able to receive treatment regimens without the use of interferon, thus eliminating the potential side effects associated with interferon that often lead patients not to start, or to complete, treatment.

"IBAVYR will offer the opportunity for Canadian health care professionals to provide patients ribavirin as part of an all-oral treatment regimen that is well-tolerated, thus allowing more patients to be treated and to achieve viral eradication," Ramji said.

The company said that until the approval of IBAVYR, ribavirin, a component of the existing standard of care for the treatment of HCV, had only been approved by Health Canada in a format that was co-packaged with pegylated interferon.

The recent approval will allow stand-alone ribavirin to be used along with new and evolving treatments, such as Sovaldi (sofosbuvir), the first treatment to allow for interferon-free therapy in genotypes 2 and 3 patients, who represent 30% of HCV cases in Canada.

Development and manufacturing of IBAVYR is carried out by Pharmascience in Canada.

Pharmascience CEO David Goodman said Pendopharm recognized this unmet need in patient treatment and is pleased to be part of the solution to bring the newest HCV interferon-free treatment regimen to physicians and patients.

"A Sovaldi and IBAVYR treatment regimen will become a trusted partnership that will change the treatment experience for some patients, and will allow physicians to treat and cure more patients," Goodman said.

"Now, PENDOPHARM will work closely with the provinces to ensure patients have access to IBAVYR and all-oral treatments as quickly as possible, in order to achieve high cure rates while improving quality of life."