First idiopathic pulmonary fibrosis drug approved
pharmafile | March 4, 2011 | News story | Sales and Marketing | Esbriet, IPF, InterMune, Orphan Drugs, idiopathic pulmonary fibrosis, orphan drug
The first ever treatment for the potentially fatal lung disease idiopathic pulmonary fibrosis (IPF) has been approved in the EU.
Esbriet (pirfenidone) has been developed by US company InterMune, and is tipped to be a blockbuster, thanks to its high-cost and first-in-class status to treat the rare disease.
The drug’s European approval for mild to moderate IPF is a major boost for the company, which suffered a setback when the FDA rejected Esbriet in May, calling for more clinical trial data.
Analysts predict Esbriet can reach in excess of $ 1billion in peaks sales, with the price of one year’s treatment expected to be around $21,000 (€15,000) a year per patient.
Idiopathic pulmonary fibrosis is a progressive disease in which the patient’s lungs become thickened and scarred by the build up of excessive collagen. This obstructs the entry of oxygen into the bloodstream, causing severe respiratory problems.
There are currently no specific treatments for the disease, which mostly affects people between 50 and 75 years old. Some patients remain stable for years after diagnosis, but many deteriorate rapidly and live just three to five years after diagnosis.
The company estimates that more than 100,000 patients suffer from IPF in the 10 most populous European countries. The majority of these, 87,000 patients, are in the five largest countries of Germany, France, Spain, Italy and the UK.
“InterMune is proud to bring the first IPF medicine, Esbriet, to patients in Europe,” said Dan Welch, chairman, chief executive and president of InterMune. “We are very pleased with our approved label for Esbriet and believe it will effectively support the access, pricing, reimbursement and marketing of Esbriet in Europe.
“The approval of Esbriet not only marks an historic moment in the treatment of IPF patients, but also an exciting new chapter for our company as we now transition to become an international commercial organisation. Our seasoned leadership team in the EU is working very diligently to make Esbriet available to European patients as soon as possible, beginning with Germany in September of this year.”
InterMune currently plans to launch Esbriet in the ‘Top 5’ EU countries over the next 18 months. After its first launch in Germany in September this year, France, Spain and Italy will follow in the first half of 2012, and then the UK in mid-2012. The company says it will also launch Esbriet in most if not all of the EU’s top 10 markets by mid-2012.
Roland du Bois, Professor of Respiratory Medicine at Imperial College in London and co-chair of the Esbriet phase III clinical programme, said: “IPF is a chronic, progressive, respiratory disease with an estimated survival rate of only 20% after five years, which makes it more lethal than many cancers, and yet no therapeutic interventions have been approved for European patients suffering from this devastating disease – until today.
“The approval of this new medicine for European patients is a landmark event in IPF care. Esbriet now offers individuals suffering from this appalling disease a novel treatment that has been shown to have a clinically meaningful effect in their disease.”
Esbriet is an oral, small molecule 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. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.
The drug has been marketed in Japan as Pirespa by Shionogi since 2008.
Esbriet’s orphan drug status in Europe gives it 10 years of marketing exclusivity lasting until 2021. InterMune also has numerous patent applications in Europe relating to Esbriet and its formulation which the company says will provide patent protection in Europe until 2030. Similar patents have been granted or are pending in the US.
Post Approval Commitments
InterMune is obliged to conduct routine safety surveillance of spontaneous adverse drug reactions (ADRs) and to conduct a PASS (Post Authorisation Safety Study) in the form of a registry to collect and monitor ADRs in patients who have been prescribed Esbriet. The PASS Registry is expected to enroll 1,000 patients over two years and to follow these patients for a similar period.
InterMune will also conduct a drug-drug interaction study to determine the impact of the antibiotic ciprofloxacin, a moderate CYP1A2 inhibitor, on the pharmacokinetics and safety of Esbriet in 25 healthy subjects.
Finally, the company will implement a risk management plan (RMP), which will include routine safety monitoring of certain adverse reactions, a patient information leaflet and a safety checklist for doctors.
Related Content
NMD Pharma’s Charcot-Marie-Tooth disease treatment granted ODD by FDA
Biotech company NMD Pharma has announced that the US Food and Drug Association (FDA) have …
Global orphan and rare dermatology market set to exceed $6 billion by 2024
The global orphan and rare dermatology premium products market is expected to grow rapidly in …
FDA approves RNA therapy for rare genetic disease
The US Food and Drug Administration has approved the RNA-based therapy Onpattro, for the treatment …
