Pfizer Gets Paid for Running a Phase 3 Programme – we can all do this.
I have just been reading a press release from the FDA that contains a really valuable insight-
Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.
Whilst most products that fail in phase 3 cost their sponsor allot of money, this one had a very powerful damage limitation programme in place, in that during the 10 years that the phase 3 was ongoing, Pfizer were selling this product, it was on the market using accelerated approval (conditional approval in Europe), its a powerful regulatory pathway that is great for all concerned.
For More information on this regulatory pathway drop me an email at action@damienbove.com
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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