FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol

BayerToday, the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) held a meeting to discuss the risk /benefit profile of Trasylol® (aprotinin injection), a Bayer drug used in coronary artery bypass graft (CABG) surgery. At the close of the meeting, based on the Trasylol data in Bayer’s controlled clinical studies and after considering data from observational studies and public testimony presented at the meeting, the Committees recommended that US marketing authorization for Trasylol should be continued.

The Committees also recommended that Bayer amend the U.S. product label for Trasylol to provide additional prescribing guidance to physicians and also recommended that Bayer conduct additional clinical studies, including randomized controlled trials, to further assess the risk and benefit of Trasylol.

Bayer was pleased to participate in today's session because it provided a proper forum in which to discuss the complex scientific issues surrounding the risk/benefit profile of Trasylol in detail. Trasylol is the only drug currently approved by the FDA for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

Patient safety is Bayer's first and foremost concern. In line with the discussions and guidance received from the Committees today, the company will work with FDA on appropriate U.S. label revisions providing additional prescribing guidance to physicians.

The Committees also recommended that Bayer undertake additional clinical studies, including randomized controlled clinical trials, to further assess risks and benefits of Trasylol. Following the Committees’ recommendation, Bayer will move forward with discussions with the FDA to reach agreement with them regarding further clinical activities.

Bayer is in close contact with other regulatory authorities around the world and will inform them of the outcome of today’s meeting and potential next steps.

Bayer considers the discussion today and the valuable feedback provided by the Committees as important guidance and input that will help the company in clarifying and addressing these critical issues. Bayer continues to believe that the totality of the medical evidence, including the RCTs and other data discussed today demonstrates that Trasylol is safe and effective when used according to the product labeling. Bayer will continue to work closely and cooperatively with all regulatory authorities to address questions regarding safe and effective use of its drugs.

About Trasylol
Important Safety Considerations
Trasylol® administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure and a history of any prior aprotinin exposure must be sought prior to Trasylol® administration. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. Trasylol® should be administered only in operative settings where cardio-pulmonary bypass can be rapidly initiated. The benefit of Trasylol® to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin. (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS in the prescribing information.)

About Bayer
Bayer is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. For more information visit www.bayer.com.

Most Popular Now

Pfizer receives positive FDA Advisory Committee vo…

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that avail...

Engineered bacteria find tumors, then alert the au…

Combining discoveries in cancer immunology with sophisticated genetic engineering, Columbia University researchers have created a sort of "bacterial suicide squad" that ...

First nasal monoclonal antibody treatment for COVI…

A pilot trial by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, tested the nasal administration of the ...

US FDA Advisory Committee votes to support effecti…

GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the avail...

"Semantic similarity" leads to novel dru…

The words that researchers use to describe their results can be harnessed to discover potential new treatments for Parkinson's disease, according to a new study published...

Tumour cells' response to chemotherapy is driven b…

Cancer cells have an innate randomness in their ability to respond to chemotherapy, which is another tool in their arsenal of resisting treatment, new research led by the...

Pfizer invests $43 billion to battle cancer

Pfizer Inc. (NYSE: PFE) and Seagen Inc. (Nasdaq: SGEN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Seagen, a...

Pfizer's ZAVZPRET™ (zavegepant) migraine nasal spr…

Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptid...

Gene and cell therapies to combat pancreatic cance…

Pancreatic cancer is an incurable form of cancer, and gene therapies are currently in clinical testing to treat this deadly disease. A comprehensive review of the gene an...

Scientists reveal a potential new approach to trea…

Scientists at the National Institutes of Health and Massachusetts General Hospital in Boston have uncovered a potential new approach against liver cancer that could lead ...

Normalizing tumor blood vessels may improve immuno…

A type of immune therapy called chimeric antigen receptor (CAR)-T cell therapy has revolutionized the treatment of multiple types of blood cancers but has shown limited e...

Digital twin opens way to effective treatment of i…

Inflammatory diseases like rheumatoid arthritis have complex disease mechanisms that can differ from patient to patient with the same diagnosis. This means that currently...