Pharma Giant Blows Whistle On Their Own Drug
Merck Sharp and Dohme, better known simply as Merck and Co., recently informed the European Medicine Agency that its medicine Tredaptive has distinct shortcomings, presenting the necessity for an extreme reevaluation.
The EMA recently learned of the products’ preliminary results of a large and long-term study, which examined the clinical effects of adding said medicine with statins, compared with statin treatment alone.
INVESTIGATION
As a result the EMA has conducted a review of the safety and efficacy of the product, also sold under brand names Pelzontand Trevaclyn,and now brought to light by Merck and Co. PRAC (the EMA’s Pharmacovigilance Risk Assessment Committee) will assess the data and henceforth make a recommendation to the CHMP (Committee on Medicinal Products for Human Use), which will issue an opinion on the way forward, expected sometime in the first quarter of this year. Healthcare professionals in the European Union (EU) will receive a letter outlining the updated information on the use of this medicine.
In the meantime the EMA recommends that no new patients should start on treatment with these specific medicines, nor should they enroll in clinical trials involving these medicines pending the outcome of the assessment. It is further recommended that patients who have any concerns or questions should consult their doctor.
"While we are disappointed in these results, we thank the investigators who have conducted the study and the patients who have participated in it," remarked president of Merck Research Laboratories Peter S. Kim (Ph.D.), "We are committed to working closely with the regulatory agencies to understand the results and determine the next steps."
SAFETY AND EFFICACY
The study found that Tredaptive when added to statins did not reduce the risk of major vascular events in stark contrast to statin therapy alone. Moreover, the study found that a higher frequency of non-fatal but serious side effects were experienced by patients taking the medicines, compared (once again) to patients only undertaking statin therapy.
"Phones will ring off the hook in cardiology practices because of the news," said cardiologist Dr. Steve Nissen of the Cleveland Clinic.
Thomas Wei, analyst for Jeffries, claims that this news could prop up the competition, namely Amarin’s Vascepa which was recently approved by the Food and Drug Administration some six months ago as therapy to lower triglyceride levels.
THE VERDICT AWAITS
It is commendable that a pharmaceutical giant would blow the whistle on its own products after citing limitations. However, despite the honesty and integrity, the company’s future has a bleak outlook.
Let’s keep this on ice for the time being and not make absolute statements; at least not until the review of the products have been concluded, during which time eyeforpharma will unveil the verdict.