Review of the EU 2020 PRIME Priority Medicines Program

The European Medicines Agency's (EMA) Priority Medicines (PRIME) program is a program designed to strengthen support for the development of drugs that are not met for medical needs.
2020, a total of 20 research drugs were identified by PRIME, the largest number since the program was launched in 2016 (although the number gap is small) and some of them targeted new therapeutic areas and adaptations.
PRIME was launched in 2016 to help companies deliver promising drugs to patients faster to meet unfinished medical needs.
EMA will provide enhanced support to organizations joining the program to help optimize their development plans and generate reliable data.
can also expect EU listing applications for final products to be reviewed under the EMA's accelerated evaluation mechanism.
this means that fast tracks are not established and it is not uncommon for products through PRIME to be reviewed within the standard time range.
84 determinations have been granted and 239 applications rejected in the five years since the PRIME program was launched.
figures are from the EMA's 2019 annual report and information released by the EMA 2020, which does not include a small number of submitted but uncensored applications because they are not covered by the program.
20 research therapeutic drugs awarded to PRIME in 2020 cover a wide range of therapeutic areas, many of which, as in previous years, target cancer or hematological diseases, half of which are advanced therapeutic drugs (ATMP).
, the majority of applications for membership in the PRIME program in 2020 were rejected, with 39 out of 60 applications rejected.
note that last year's rejection rate was the lowest (65 per cent), while previous years' rejection rates were between 72 and 78 per cent.
number of GRANT awards and rejections for the period 2016-2020 can be found below: PRIME has strict eligibility criteria.
applicants must convince the EMA that, based on early clinical data, their research products have the potential to benefit patients with untreated needs, a requirement that most businesses find difficult to meet.
But not accepting a drug under the PRIME program does not mean that the drug should not continue to be developed, and the EMA has noted that "drugs that are not recognized by PRIME can still benefit patients by providing alternative treatment options for the disease."
"One of last year's most notable PRIME identifies as Akero's efruxifermin (EFX) for the treatment of non-alcoholic fatty hepatitis (NASH).
there are currently no approved drugs for NASH in major markets, including the European Union and the United States, although Cadila was approved in India last year to use its diabetic blood lipid abnormalities and high triglycerides drug saroglitazar as an NASH treatment.
, according to Akero, the PRIME determination of its research FGF21 similar "provides important evidence of EFX's potential as a basic NASH monotherapy."
companies emphasize that "not only is there a high level of unseolved demand for drugs to treat this life-threatening disease," but EFX also has the multi-faceted potential to address NASH and its associated mergers.
, PhaseBio's Bentracimab and Acceleron's Sotatercept, two biologic drugs that became the first cardiovascular drugs to join the program.
Bentracimab (PB2452) is used to reverse the antiplate plate plate activity of Tikagre in haemorrhage, while sotatercept is used to treat pulmonary hypertension.
Insmed's Brensocatib became the first lung-allergy product to enter the PRIME program for the treatment of non-cystic fibrosis bronchid expansion.
list of 20 drugs approved by PRIME by 2020 is as follows: The PRIME program is similar to the U.S. FDA's Breakthrough Therapeutic Recognition (BTD) program.
BTD aims to accelerate the development and review of drugs intended to be used to treat serious diseases, and the preliminary clinical evidence of these drugs suggests substantial improvements in clinically meaningful endpoints compared to existing therapeutic drugs.
products in the prime program have also been recognized by BTD.
difference between the EU and US programs is that PRIME supports only one adaptive disorder per product, while BTD can be used for multiple allergies.
addition , nine drugs will be approved under the PRIME scheme in 2020 , bringing the total number of drugs approved for use in Europe through the PRIME scheme to 13 so far ( see table below ) .
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