Esbriet® (pirfenidone) receives FDA approval under ‘breakthrough status’; Diplomat to distribute
FLINT, Mich., — Oct.16, 2014 — Diplomat, the nation’s largest independent specialty pharmacy, announced today that it has a contract to distribute Esbriet (pirfenidone), which was approved Oct. 15, 2014 by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis. In addition to the breakthrough therapy designation, Esbriet was also granted the orphan drug designation and received priority review.
Manufactured by InterMune Inc., Esbriet is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that plays a key role in fibrosis, or scarring, in the lungs. Esbriet will be available in 260mg, 270-capsule bottles. Esbriet was approved by the FDA under the breakthrough therapy designation as a drug that addresses a serious or life-threatening condition and for which clinical evidence indicates potential for a significant improvement over existing therapies. The drug also received the orphan therapy designation as treatment for a rare disease, along with priority review.
“We are pleased to partner with InterMune Inc. as a specialty pharmacy provider of Esbriet,” said Gary Kadlec, R.Ph, president of Diplomat. “Diplomat’s proven expertise in handling limited-distribution drugs and high-touch patient care model support our commitment to provide Esbriet in accordance with our high standards.”
According to the Coalition for Pulmonary Fibrosis, approximately 128,100 people in the United States are affected by IPF, with 40,000 deaths attributed to the disease annually. IPF is a progressive disease characterized by scarring of the lung lining, which causes irreversible loss of the tissue’s ability to transport oxygen. Esbriet is the first FDA-approved treatment for IPF.
Full prescribing information is available on the manufacturer’s website, http://www.intermune.com/pirfenidone
Diplomat (NYSE: DPLO) serves patients and physicians in all 50 states. Headquartered in Flint, Michigan, the company focuses on medication management programs for people with complex chronic diseases, including oncology, immunology, hepatitis, multiple sclerosis, HIV, specialized infusion therapy and many other serious or long-term conditions. Diplomat opened its doors in 1975 as a neighborhood pharmacy with one essential tenet: “Take good care of patients, and the rest falls into place.” Today, that tradition continues – always focused on improving patient care and clinical adherence. For more information visit www.diplomat.is.
Gary Rice, R.Ph, Diplomat
810.768.9865 | email@example.com