PharmaKnowledge Forums article The world’s biggest pharmaceutical company, Pfizer, is pulling a new, experimental drug from clinical trials, the first such withdrawal in the history of the European Medicines Agency (EMA).
A statement by the company on Friday said it would not resume trials of the drug, Risperdal, because of a new regulatory directive.
It said it was withdrawing the drug from Phase 1 trials in Europe and Asia.
The drug has been approved for the treatment of people with serious and chronic fatigue syndrome (ME/CFS).
The move was the latest twist in a legal battle that began when the FDA banned Pfizer from selling Rispendal to Medicare on the grounds that it does not comply with the current standard of care.
The EMA, which oversees all clinical trials in the US, has been looking into the drug for more than a year.
Pfizer’s withdrawal was not surprising, said Dr Mark Withers, who studies the EMA at University College London.
“The EME has been watching closely the development of the company and has decided that they have gone beyond what the EME requires.”
The European Medicine Agency has a strong interest in the safety and effectiveness of drugs.
It’s clear that the EMMA needs to do more to understand the company’s decision, said Andrew Stobbart, an associate professor at the University of Oxford.
“It’s really unfortunate that the company is withdrawing a drug that is already approved for this population.”
In its statement, Pfiser said it planned to continue the Phase 1 clinical trials.
The drug was withdrawn because it did not meet the standard of safety, the company said.
Pharmaceutical companies are under fire from some patients and advocacy groups for not being able to meet a new standard of effectiveness and safety that Pfizer set.
Earlier this year, Pfizers pharmaceutical arm AstraZeneca pulled a drug from a phase 3 trial in India after it was found to be not as effective as the standard.
The company said it could not comply “with the current EMA standard for a treatment for chronic fatigue and ME/CFT [Multiple Sclerosis].”
But a spokesman for the EMBA said it is still evaluating Rispedal.
AstraZeneca said it did so because the drug was “no longer meeting the current clinical trial objectives, as set out in the clinical trial objective list, for use in patients with ME/ CFS”.
PharmaKnowhow, a forum for medical research, said on Friday that a study of Rispardal showed it was “likely to be ineffective” and “not efficacious” in ME/cFS patients.
Last week, the US Food and Drug Administration (FDA) said it had withdrawn Risqueldal from approval, saying it did too little to show it could be used safely in people with the condition.
Its withdrawal comes less than two months after the EEMA issued a new regulation, requiring companies to report data showing that they meet the current drug standard for the most common disease.
There is no way to know if Pfizer complied, said Stobbard.
He added that there was “some evidence that Risepal might have some efficacy in ME patients, but that’s still a very preliminary result”.
It was the first time a drug had been withdrawn from clinical trial, said Richard Heffernan, a professor of medicine at Stanford University who specializes in the medical treatment of chronic fatigue.
“This is really a wake-up call to pharmaceutical companies that this is a very large problem,” he said.
“There is still no real indication that this drug will be effective in ME.”
Heffernon added that “this is one of the biggest regulatory hurdles for pharmaceutical companies to clear” in the drug development process.
Risperdals makers said in a statement that they were reviewing the regulatory guidance and “considering all options for a future decision”.
“Rispardals current clinical trials are now underway, and Pfizer is currently withdrawing this drug from its Phase 1 and 2 trials in European and Asia,” the company added.
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