PHARMACY

FDA approves Imbruvica expansion to treat chronic graft versus host disease

BY David Salazar

SILVER SPRING, Md. — Janssen Biotech and Pharmacyclics’ Imbruvica (ibrutinib) has a new indication. The Food and Drug Administration on Wednesday approved the drug to treat adults with chronic graft versus host disease after one or more treatments have failed.

This approval makes Imbruvica the first FDA-approved treatment for the illness, which afflicts patients who have received hematopoietic stem cell transplantation to treat blood or bone marrow cancers. The illness occurs when cells from the stem cell transplant attack healthy cells in a patient’s tissues.

"Patients with [chronic graft versus host disease] who do not respond to other forms of therapy — typically corticosteroids to suppress their immune system — now have a treatment option specifically indicated to treat their condition," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "This approval highlights how a known treatment for cancer is finding a new use in treating a serious and life-threatening condition that may occur in patients with blood cancer who receive a stem cell transplant."

Imbruvica has previously been approved for certain indications in treating chronic lymphocytic leukemia, Waldenström's macroglobulinemia and marginal zone lymphoma, as well as under accelerated approval status for mantle cell lymphoma. The drug received priority review and breakthrough therapy designations, as well as orphan drug designation for this indication.

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PHARMACY

Diplomat named distributor of newly approved Nityr

BY David Salazar

FLINT, Mich. — Diplomat Pharmacy will be exclusively dispensing Cycle Pharmaceuticals’ Nityr (nitisinone) tablets, the company announced Thursday. The Food and Drug Administration approved Nityr on Aug. 1 to treat the rare disease hereditary tyrosinemia Type 1, or HT-1, in combination with dietary restriction of tyrosine and phenylalanine.

“At Diplomat, our care team works vigorously to ensure our patients receive innovative therapy solutions while providing the high-touch care they deserve," Diplomat president Paul Urick said. “As the sole distributor, we are excited to offer a new treatment option for patients seeking a more convenient therapy and in need of support. Cycle Pharmaceuticals has interpreted the modern health needs of HT-1 patients and caregivers by successfully developing a new treatment to improve their quality of life.”

While there are currently capsules and oral suspensions of nitisinone available, Nityr tablets don’t require refrigeration and it also is available for infants or patients with difficulty swallowing through an oral syringe. The drug is available in 2-, 5- and 10-mg dosage strengths.

“Nityr is the first milestone in the long-term engagement of Cycle Pharmaceuticals with the HT-1 community,” Cycle Pharmaceuticals CEO Antonio Benedetti said when the drug was approved. “ We look forward to working with physicians, caregivers and the patient community to help HT-1 patients benefit from the developments that Nityr brings.”

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FDA approves new indication for Kalydeco

BY David Salazar

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday approved a new indication for Vertex Pharmaceuticals’ Kalydeco (ivacaftor). The new indication is for use in more than 600 people with cystic fibrosis ages 2 years and older who have one of five residual function mutations.

“In the five years since KALYDECO became the first approved medicine to treat the underlying cause of cystic fibrosis, we have been relentless in our efforts to bring this important medicine to all who may benefit,” Vertex chief medical officer Dr. Jeffrey Chodakewitz said. “We will continue to pursue this goal until all people with CF have a medicine that treats their form of this serious and life-shortening disease.”

The drug now is approved in the United States to treat cystic fibrosis patients ages 2 years and older with one of 28 ivacaftor-responsive mutations in the cystic fibrosis transmembrane conductance regulator, or CFTR, the company said.

The illness is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. There are approximately 2,000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, lead to CF by creating defective or too few CFTR proteins at the cell surface.

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