A new initiative to support drug companies developing therapies with the potential to address unmet medical needs and bring them to market more quickly has been launched by the European Medicines Agency (EMA).
Companies will be appointed an individual expert from the EMA to guide them in producing robust clinical evidence to support the potential of their products. If a drug is backed by the necessary clinical trial evidence, it could be fast-tracked under the EMA’s accelerated assessment programme for marketing authorisation.
Products likely to be considered under the Priority Medicines Scheme (PRIME) are those that have the potential to provide a major therapeutic advantage over existing treatments or that benefit patients without treatment options. The EMA highlights rare cancers, Alzheimer’s disease and other dementias as possible therapeutic areas. It also suggests that eligible drugs could target a chronic condition like asthma but be administered in a new way to benefit patients.
Launching the scheme on 7 March 2016, the EMA’s executive director Guido Rasi said: “Our goal is to foster better planning of medicine development to help companies generate the high quality data we need to assess quality, safety and efficacy of medicines.”
The EMA says PRIME is different from the existing orphan drugs scheme because orphan drug status is only awarded to products with the potential to treat rare conditions that have an unmet clinical need. Products with orphan drug status are also given long-term marketing advantages, according to an EMA spokesperson.