CHMP recommends label update for Esbriet in idiopathic pulmonary fibrosis, strengthening mortality benefit and reinforcing safety profile

• Pooled analysis of ASCEND and two CAPACITY phase III trials show 48 percent reduction in mortality risk at one year¹
• ASCEND data reinforces the Esbriet safety and efficacy profile¹
• Approximately 110,000 people in Europe have idiopathic pulmonary fibrosis (IPF), an irreversible, progressive, fatal lung disease^{2- 5}
• Only 20–40 percent of IPF patients survive five years after diagnosis^6,7

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Esbriet® (pirfenidone) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for an update to its European prescribing information, strengthening the efficacy claims and supporting the well-established safety profile based on the additional data from the phase III ASCEND trial. Approved in the EU in 2011, Esbriet is indicated for the treatment of adults with mild to moderate IPF.

The CHMP recommendation includes data from the phase III ASCEND study, which showed that the proportion of patients with ≥10 percent decline in forced vital capacity (FVC) – a measure indicative of the risk of mortality in IPF – was significantly reduced in patients receiving Esbriet compared with patients receiving placebo at one year.¹ Also included in the label update is a pre-specified pooled analysis from ASCEND and the two phase III CAPACITY trials that showed that the risk of all-cause mortality was reduced by 48 percent in Esbriet-treated patients compared with the placebo group at one year.^1,2 The pooled analysis also showed that the risk of treatment-emergent IPF-related mortality in the Esbriet group compared to placebo was reduced by 68 percent in the pooled population at one year.¹

“This recommendation from the CHMP acknowledges the compelling evidence for Esbriet to reduce the progression of this deadly disease in people with IPF,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche. “The inclusion of the ASCEND data in the European prescribing label for Esbriet will provide important additional information for physicians and patients.”

Following the CHMP positive opinion, the EU prescribing information will now be updated to include the ASCEND data. On October 15, the FDA approved Esbriet in the United States, under the Breakthrough Therapy Designation.

IPF is a fatal disease caused by irreversible, progressive scarring (fibrosis) of the lungs, which makes breathing difficult and prevents the heart, muscles and vital organs from receiving enough oxygen to work properly.⁸ The disease can advance quickly or slowly, but eventually the lungs will harden and stop working altogether.⁸ IPF’s rapid decline is often worse than many malignancies, including breast, ovarian and colorectal cancers.⁹

In August 2014, Roche and InterMune announced that they have entered into a definitive merger agreement for Roche to fully acquire InterMune. The transaction was completed in September 2014.

“This label amendment reinforces Esbriet’s role as an important treatment option for patients with IPF,” said Jonathan Leff, M.D., Executive Vice President of Research and Development at InterMune. “Patients and their caregivers can remain confident in the safety and efficacy profile of Esbriet.”

References

1. King TE Jr. Bradford WZ, Castro-Bernardini S. A. N Engl J Med 2014; 370(22):2083−92
2. Eurostat News Release. Available at http://ec.europa.eu/eurostat. Accessed on 7 October 2014
3. Coultas DB et al. Am J Respir Crit Care Med 1994;150:967−997
4. Hodgson U et al. Thorax 2002; 57:338−342
5. Meltzer EB, Noble PW et al – Orphanet J Rare Dis (2008); 3:8−22
6. Bjoraker JA et al. Am J Respir Crit Care Med 1998;157:199−203
7. Collard HR et al. Am J Respir Crit Care Med 2003; 168:538–542
8. American Thoracic Society/European Respiratory Society. Am J Respir Crit Care Med 2002; 165:277−304
9. Cancer Facts and Figures 2009, American Cancer Society. PAH data source: Hamilton, N. and Elliot C.