Bristol-Myers Squibb Pharma EEIG withdraws its marketing authorisation application for DuoCover

The European Medicines Agency (EMEA)The European Medicines Agency (EMEA) has been formally notified by Bristol-Myers Squibb Pharma EEIG of its decision to withdraw its application for a centralised marketing authorisation for the medicine DuoCover (fixed-dose combination tablets of 75 mg clopidogrel/75 mg acetylsalicylic acid and 75 mg clopidogrel/100 mg acetylsalicylic acid). DuoCover was expected to be used by patients already taking clopidogrel and acetylsalicylic acid for the approved indication of prevention of atherothrombotic events in acute coronary syndrome.

The application for marketing authorisation for DuoCover was submitted to the EMEA on 30 May 2007. At the time of the withdrawal, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).

In its official letter, the company stated that the withdrawal of DuoCover was based on the request of the CHMP regarding the need to document bioequivalence based on the current guideline on bioavailability and bioequivalence. The company informed in the letter that it intends to perform a new bioequivalence study measuring plasma levels of clopidogrel parent compound to address the CHMP's request but the results of that study will not be available in the timelines defined by the centralised procedure.

More information about DuoCover and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website shortly.

For further information, please visit:
http://www.emea.europa.eu

Most Popular Now

AstraZeneca enters license agreement with KYM Bios…

AstraZeneca and KYM Biosciences Inc.* have entered into a global exclusive licence agreement for CMG901, a potential first-in-class antibody drug conjugate (ADC) targetin...

Pfizer's elranatamab receives FDA and EMA filing a…

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company's Biologics License Application (BLA) ...

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...

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...

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 ...

"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...

Nanosatellite shows the way to RNA medicine of the…

The RNA molecule is commonly recognized as messenger between DNA and protein, but it can also be folded into intricate molecular machines. An example of a naturally occur...

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...

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 ...

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...

AI conjures proteins that speed up chemical reacti…

For the first time, scientists have used machine learning to create brand-new enzymes, which are proteins that accelerate chemical reactions. This is an important step in...