EsbrietTreatment for Idiopathic Pulmonary Fibrosis
Update: Esbriet (pirfenidone) Now FDA Approved - October 15, 2014
InterMune Announces Expanded Access Program for Pirfenidone to Treat Idiopathic Pulmonary Fibrosis (IPF) in the United States
BRISBANE, Calif., May 16, 2014 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced it will provide compassionate use of pirfenidone through a multi-center Expanded Access Program (EAP) in the United States to be conducted under InterMune's U.S. IND. Pirfenidone is an investigational therapy in the U.S. and has not been approved by the U.S. Food and Drug Administration (FDA).
Expanded access programs provide a mechanism for early access to an investigational drug in the pre-approval period to treat patients with a serious or immediately life-threatening disease or condition that has no comparable or satisfactory alternative treatment options.
"We are pleased to offer this expanded access program for eligible patients in the U.S.," said Jonathan Leff, M.D., Executive Vice President of Research and Development, InterMune. "This EAP provides a mechanism for eligible patients to access pirfenidone as a treatment option, following the recent successful completion of our ASCEND Phase 3 trial and prior to FDA's final decision on the approvability of pirfenidone in the United States."
To enroll in the EAP, a patient must meet specific clinical criteria. Eligible patients must have a clinical and radiographic diagnosis of IPF with the presence of a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT). Additional criteria for the EAP are listed on www.clinicaltrials.gov. It is important to note that only a physician who is participating in the EAP can assess a potential patient for eligibility. The EAP protocol contains provisions for stopping enrollment of patients in the EAP upon a decision by the FDA on the approvability of a pirfenidone New Drug Application (NDA).
There are currently a limited number of sites accepting patients for enrollment to the pirfenidone EAP and InterMune expects that all sites will be participating by September of 2014. InterMune is working with the Pulmonary Fibrosis Foundation (PFF), the Coalition for Pulmonary Fibrosis (CPF) and other advocacy groups to enable patients with IPF to obtain information about the pirfenidone EAP.
For more information about the pirfenidone EAP, including eligibility criteria and participating clinical centers, contact InterMune Medical Information at 888-486-6411 or the Pulmonary Fibrosis Foundation (PFF) at 844-TalkPFF (844-825-5733) or visit www.clinicaltrials.gov.
Idiopathic pulmonary fibrosis (IPF) is an irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis (scarring) in the lungs, which hinders the ability of lungs to absorb oxygen. IPF inevitably causes shortness of breath, and a deterioration in lung function and exercise tolerance. IPF patients follow different and unpredictable clinical courses and it is not possible to predict if a patient will progress slowly or rapidly, or when the rate of decline may change. Periods of transient clinical stability in IPF, when they occur, inevitably give way to continued disease progression. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers. IPF typically occurs in patients over age 45, and tends to affect slightly more men than women.
Pirfenidone is an orally active, anti-fibrotic agent 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. Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive, irreversible, unpredictable and ultimately fatal lung disease. Pirfenidone is not approved for marketing in the United States. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation InterMune's expectations regarding the availability of its Expanded Access Program for patients in the U.S. with IPF. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Other factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 24, 2014 (the "Form 10-K") and other periodic reports filed with the SEC, including but not limited to the following: (i) the risks related to the uncertain, lengthy and expensive clinical development process for the company's product candidates, including having no unexpected safety, toxicology, clinical or other issues and having no unexpected clinical trial results such as unexpected new clinical data and unexpected additional analysis of existing clinical data; (ii) risks related to the regulatory process for the company's product candidates, including the possibility that the results of the new 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in the United States; (iii) risks related to unexpected regulatory actions or delays or government regulation generally; and (iv) risks related to the company's manufacturing strategy, which relies on third-party manufacturers and which exposes InterMune to additional risks where it may lose potential revenue. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.
SOURCE InterMune, Inc.
Posted: May 2014
- FDA Approves Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis - October 15, 2014
- InterMune Receives FDA Breakthrough Therapy Designation for Pirfenidone, an Investigational Treatment for IPF - July 17, 2014
- InterMune Announces Resubmission Of NDA For Pirfenidone For The Treatment Of Patients With IPF - May 27, 2014
- InterMune Reports Phase 3 ASCEND Trial Results of Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF) - February 25, 2014
- Coalition for Pulmonary Fibrosis Responds to News of Further Review of Pirfenidone By FDA - May 7, 2010
- InterMune Receives FDA Complete Response Letter on Esbriet (pirfenidone) New Drug Application - May 5, 2010
- FDA Advisory Committee Recommends Approval of InterMune's Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis - March 10, 2010
- InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone - March 5, 2010
- FDA Grants Priority Review of Pirfenidone NDA for the Treatment of Patients With IPF - January 6, 2010
- InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF - November 4, 2009