PHARMACY

FDA Reauthorization Act heads to Trump’s desk after Senate passage

BY David Salazar

WASHINGTON — The Senate on Thursday voted to pass the Food and Drug Administration Reauthorization Act of 2017, sending the bill to the desk of President Donald Trump following the House’s passage of the legislation in June. The bill contains the reauthorizations of the FDA’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.

“Working together, House and Senate Republicans and Democrats brought forth a bill to reauthorize these important programs, putting patients first and their hope for new treatments within reach,” said Senate Energy and Commerce Committee chairman Greg Walden, R-Ore.; ranking member Frank Pallone, Jr., D-N.J.; Health Subcommittee chairman Dr. Michael Burgess, R-Texas; and Health Subcommittee ranking member Gene Green,D-TX).“This bill is a win for patients and the millions of Americans working to develop our next generation of cures and therapies. We applaud the Senate’s swift action in passing this vital bill, and urge President Trump to sign it into law.”

The bill’s passage immediately drew praise from the industry, including Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America.

“PhRMA applauds the Senate for passage of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts,” Ubl said. “PDUFA VI better incorporates real-world evidence and patient perspectives into the drug development and approval process, while also providing the [FDA] with new tools and resources to keep up with the latest scientific advances. By strengthening the FDA and improving efficiency in the drug review process, we can bring safe, innovative medicines to patients faster, which will enhance competition and lower costs. This is a major victory for medical innovation, the FDA and patients.”

The Biotechnology Innovation Organization also weighed in, saying that the bill contained provisions that would help accelerate and incentivize the entry of generics and biosimilars to the market.

“[The bill] ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development,” BIO president and CEO James Greenwood said. “The reauthorization of the biosimilars user fee program, including steps to improve communication between the FDA and Sponsors throughout application review, will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products.”

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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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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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