PRIME Addressing patients’ needs PRIME aims to bring promising medicines that meet regulatory requirements to patients earlier by optimising and supporting their development. The scheme focuses on medicines that address an unmet medical need and that have the potential to bring a major therapeutic advantage to patients. With PRIME, EMA translates scientific advances into the development of medicines that can make a real difference to patients’ lives.

96

requests processed (between April 2016 and April 2017)

May

4

14

June

2

July

2

7 1

September

2

7

October

6

December 1

6

February

2

March

(by type of medicine)

12 biological medicines 2 (of which 1 orphan medicine) chemical medicines which 3 orphan medicines) 5 (of 1 vaccine

advanced therapies (of which 8 orphan medicines)

1 in 3

medicines targets a disease for which no treatment exists

PRIME medicines

(by therapeutic area) Oncology

Haematology/Haemostaseology 6

2

Neurology 2 8 1 Gastroenterology/Hepatology 2

3 4

April 1

4 Granted

22%

Denied

Out of scope

success rate

requests denied

71

20 requests granted

6

6

November 1

2

The European Medicines Agency (EMA) developed its PRIority MEdicines (PRIME) scheme in line with the European Commission's priorities and the European medicines regulatory network’s strategy to 2020.

6 1

3

January

The first 12 months

(multiple reasons in some cases)

~70% Data not sufficiently robust ~40% Justification of therapeutic advantage insufficient ~20% Development too advanced

Vaccines 1 Immunology/Rheumatology/Transplantation 1 Endocrinology/Gynaecology/Fertility/Metabolism 1 Psychiatry 1

PRIME - The first 12 months - European Medicines Agency

>PRIME aims to bring promising medicines that meet regulatory requirements to patients earlier by optimising and supporting their development. >The scheme ...

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