The Health Canada has approved InterMune, Inc.'s Esbriet (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adult patients. IPF is a progressive and uniformly fatal disease that affects approximately 5,000 to 8,000 Canadians, is characterized by scarring of lung tissue, and has a similar short life expectancy to that of many forms of cancer, including lung, colorectal and breast cancers.
Health Canada designated Esbriet for Priority Review and completed the accelerated review according to target guidelines of 180 days.
"After over a decade of failed clinical trials of multiple innovative drugs for IPF, today's announcement of Health Canada's approval of Esbriet is an exciting one for IPF patients and the larger IPF community," said Charles Chan, MD, an IPF researcher and consultant respirologist at University Health Network, professor and vice-chair of Medicine, University of Toronto. "I am very pleased to finally have a treatment option with proven benefit for patients with this challenging disease."
Pirfenidone is the first and only medicine approved anywhere in the world for the treatment of IPF. In addition to Canada, pirfenidone is approved in 29 European countries under the InterMune trade name Esbriet and in Japan and South Korea where it is marketed by Shionogi & Co. Ltd under the trade name Pirespa. Under different trade names, pirfenidone is also approved for the treatment of IPF in China, India, and Argentina. InterMune is conducting an additional phase III study, ASCEND, to support the regulatory registration of Esbriet for the treatment of IPF in the United States.
"With the approval of Esbriet by Health Canada we are very pleased to have made another big step toward our objective to bring Esbriet to as many IPF patients as possible – and as soon as possible," said Daniel Welch, chairman, CEO and president of InterMune.
While Health Canada has now approved Esbriet for the treatment of mild to moderate IPF in adult patients, it is not yet available for sale in Canada. InterMune expects that Esbriet will be available on January 1, 2013. The company is currently working to secure reimbursement of Esbriet from private insurance providers and the public (provincial) drug reimbursement plans in Canada. Approximately one-third of IPF patients in Canada are covered by private insurance and InterMune expects to secure private insurance coverage from some private insurance plans in the first quarter of 2013 and from substantially all of the private insurance plans in the second quarter of 2013. Public (provincial) drug reimbursement plans cover approximately two-thirds of IPF patients in Canada and reimbursement of new medicines from these plans is typically secured within six to 18 months of launch.
Preclinical and in-vitro evidence suggests that Esbriet has both anti-fibrotic and anti-inflammatory effects. In its clinical development programme, Esbriet was demonstrated to be effective in decreasing decline in lung function, slowing the progression of the disease and preserving exercise tolerance.
Esbriet was also safe and generally well-tolerated with the most frequent side effects reported being rash and gastrointestinal symptoms. The safety and tolerability of Esbriet in IPF patients is well-characterized based on both clinical studies and the expanding post marketing experience. Safety results from ongoing studies of Esbriet demonstrated that long-term treatment with Esbriet for up to 7.7 years was safe and generally well-tolerated, with a long-term safety profile similar to that observed in Esbriet's original clinical study programme.
Esbriet is an orally active drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis, or scarring, of the lung. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.
On February 28, 2011, the European Commission granted marketing authorization for Esbriet in adults for the treatment of mild to moderate IPF. The approval authorized marketing of Esbriet in all 27 EU member states. Esbriet has since also been approved for marketing in Norway and Iceland -- and now, Canada. Esbriet is now commercially available in Austria, Denmark, Germany, Iceland, Luxembourg, Norway and Sweden, and is expected to be made available in France by the end of 2012.
Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs that compromises lung function and hinders gas exchange. IPF is a progressive disease, meaning that over time, lung scarring, symptoms, and functional limitations increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20-40 per cent, which makes IPF more rapidly lethal than many cancers, including ovarian, colorectal, and breast. Patients diagnosed with IPF are primarily between the ages of 40 and 80, with a median age of 63 years. The disease tends to affect slightly more men than women.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases.