USFDA Drug Safety : FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death

FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases.

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems. Health care professionals should not change the way they prescribe these drugs at this time.

The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on November 16, 2014. FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.

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North Carolina drugmaker "Chimerix" gets FDA approval to provide experimental treatment to Ebola patients

CHEMIREX INC., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced that brincidofovir has been provided for potential use in patients with Ebola Virus Disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications (EIND) were granted by the U.S. Food and Drug Administration (FDA).

Chimerix is working closely with the FDA to finalize a clinical trial protocol early this week to assess the safety, tolerability, and efficacy of brincidofovir in patients who are confirmed to have an infection with the Ebola virus. Testing at the Viral Special Pathogens Branch of the CDC and the NIH revealed in vitro (test tube) activity of brincidofovir against the Ebola virus that was similar to that seen in test tube assessments of brincidofovir against other viral diseases, such as adenovirus and smallpox. Additional tests of brincidofovir in in vivo (animal) models of Ebola virus infection are currently underway.

Chimerix's lead product candidate, brincidofovir, is an oral nucleotide analog that has shown broad-spectrum in vitro antiviral activity against all five families of DNA viruses that affect humans, including viruses in the herpes virus family and adenovirus. Brincidofovir has shown no evidence of kidney or bone marrow toxicity in nearly 900 patients treated to date. Building on the positive Phase 2 results in cytomegalovirus (CMV) prevention, Chimerix initiated the Phase 3 SUPPRESS trial in 2013. If positive, data from SUPPRESS will support Chimerix's initial regulatory submission for brincidofovir for the prevention of CMV infection in adult hematopoietic cell transplant (HCT) recipients. Chimerix recently initiated AdVise, a Phase 3 trial in adenovirus, which is an often-fatal viral infection with no approved treatment; enrollment is ongoing for the pilot portion of the trial. Chimerix is also working with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir as a medical countermeasure against smallpox. Brincidofovir has received Fast Track designation from the FDA for CMV, adenovirus, and smallpox.

"Chimerix is committed to working with global health organizations and government agencies in the fight against the Ebola virus outbreak," said M. Michelle Berrey, M.D., M.P.H., President and Chief Executive Officer of Chimerix. "Based on in vitro data from work conducted by the CDC and the National Institutes of Health suggesting brincidofovir's activity against Ebola, we are hopeful that brincidofovir may offer a potential treatment for Ebola Virus Disease during this outbreak. Data collected over years of clinical development of brincidofovir have allowed us to progress this compound into Phase 3 programs for cytomegalovirus and adenovirus infections, and provided information on the safety and dosing of brincidofovir to allow it to be explored as a potential therapy for Ebola Virus Disease."

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