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."
FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.
Par said Thursday that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.
The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.
NACDS applauds NEHI report demonstrating importance of medication adherence
ALEXANDRIA, Va. — The National Association of Chain Drug Stores Foundation on Thursday applauded a report illustrating the impact medication adherence can and should have on reducing hospital readmission rates, and the critical role community pharmacists play in coordinated care approaches to enhancing patient medication adherence.
The report “Thinking Outside the Pillbox: Improving Medication Adherence and Reducing Readmissions,” issued by the national health policy institute NEHI, found that a significant portion of hospital readmissions of Medicare patients are caused by medication-related adverse events. One-third of adverse drug events resulting in a hospital admission were related to nonadherence.
“Medication management is at the core of advanced discharge planning and transitional care. This reflects three realities: adverse events are a major cause of avoidable hospital readmissions; more post-discharge adverse events are related to drugs than other causes; and lack of adherence to medications prescribed at discharge has been shown to be a driver of post-discharge adverse drug,” the report found.
The report also points to lack of coordination between healthcare providers. Innovative models that include multidisciplinary healthcare teams — including community pharmacists — can help improve patient health following discharge from the hospital, which also reduces the cost of repeat hospitalizations to the healthcare system.
The NEHI report affirms the role community pharmacy can play in helping patients to avoid hospital readmissions and adverse events post-discharge,” stated NACDS Foundation president Kathleen Jaeger. “Community pharmacists collaboratively work with hospitals, physicians, nurses and other healthcare providers in helping patients understand the importance of taking their medications as prescribed and improving medication adherence, facilitating the transition from hospital to home.”
The NACDS Foundation is also currently conducting research on “primary medication adherence,” which will examine the impact of medication management services on patient health outcomes within existing medical homes or accountable care organization delivery models.
“The utilization of care teams is increasingly recognized as an effective strategy to remedy the often fragmented healthcare delivery system by coordinating treatment to improve health outcomes and reduce healthcare costs,” Jaeger stated. “The NACDS Foundation will continue to work to help patients improve their health through an understanding of medication therapy and the importance of taking medications properly.”
To view the full report, click here.