FDA approves Teva’s Synribo for blood and bone marrow cancer
SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.
The FDA announced the approval of Teva Pharmaceutical Industries’ Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.
"Today’s approval provides a new treatment option for patients who are resistant to or cannot tolerate other FDA-approved drugs for chronic or accelerated phases of CML," FDA Office of Hematology and Ongology Products director Richard Pazdur said.
The drug is the second one approved for CML in two months. Last month, the agency approved Pfizer’s Bosulif (bosutinib) for patients for chronic, accelerated or blast-phase Philadelphia chromosome-positive CML who are resistant to or can’t tolerate other therapies.
Prime Therapeutics president, CEO to deliver keynote address at Therigy event
ST. PAUL, Minn. — The leader of pharmacy benefit manager Prime Therapeutics will be the keynote speaker at a specialty pharmacy conference Thursday.
Prime said president and CEO Eric Elliott would deliver the keynote speech, titled "Specialty Pharmacy Benefit – The Employer’s Perspective" at the first annual Therigy Specialty Pharmacy Leadership Congress in Orlando, Fla.
"It is vital to have a clear view into all components of specialty drug management and to be able to manage the constantly moving parts that play into it," Elliott said. "We need to connect to and coordinate with the health plan, the provider and the patient across the entire care continuum. In this way, we can close gaps in care that sometimes surface due to the complex nature of specialty management and the fact that several doctors and specialists may be involved in the patient’s overall care."
FDA declines approval of United Therapeutics PAH drug
SILVER SPRING, Md. — The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.
The drug maker said it received a complete response letter from the agency for its application for a tablet formulation of the drug treprostinil. The company already markets the drug in injectable and inhaled formulations for pulmonary arterial hypertension, or PAH, a condition that causes high blood pressure in the arteries of the lungs.
The FDA issues a complete response letter when it has finished reviewing a regulatory application for a drug, but questions remain that preclude approval. The FDA’s letter called into question the importance of a measure of efficacy called "6-minute walk distance," or 6MWD, and also raised concerns about the inability to show a significant effect on 6MWD in one of the clinical trials and the inability to show an improvement in time to clinical worsening.
"We will continue using our best efforts to gain approval of oral treprostinil, and we will focus on doing so within the next four years," United chairman and CEO Martine Rothblatt said. "We will convene with our experts over the next several weeks to decide which of several paths forward to pursue."