Release date- 23082019 - STOCKHOLM - OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), today announced that, based on a positive opinion from the Paediatric Committee
(PDCO), the EMA has agreed to the proposed PIP for Oxalobacter formigenes in the treatment of primary hyperoxaluria.
- The Paediatric Committee
(PDCO) of the European Medicines Agency (EMA) has accepted US-based therapeutics developer Emmaus Life Sciences' pediatric investigation plan (PIP) for its treatment of sickle cell disease, the company said.
The EMA's Paediatric Committee
(PDCO) supported the paediatric investigation plan (PIP) for the development of captopril, a drug designed to treat heart failure in children.
EU: MORE DISCRETION FOR THE PAEDIATRIC COMMITTEE
WHEN DECIDING ON A PAEDIATRIC INVESTIGATION PLAN (PIP) THE 'NYCOMED DECISION'
The company said that previously the Paediatric Committee
(PDCO) of the EMA adopted an opinion agreeing to the PIP and a deferral of the initiation of the clinical studies until after the drug receives EMA approval.
The regulation provides for the establishment at EU level of an expert PDCO (Paediatric Committee
) within the EMEA (European Medicines Agency).
Ministers accepted amendments passed by the European Parliament this June that among other things, insisted in the independence of the EU paediatric committee
monitoring children's medicines, and approving special investigation plans into medicines under market authorisation procedures.
In line with Parliament's demands, the compromise enhances the independence of the Paediatric Committee
. It therefore states that: "Members of the Paediatric Committee
should (...) not have financial or other interests in the pharmaceutical industry which could affect their impartiality, should undertake to act in the public interest and in an independent manner, and should make an annual declaration of their financial interests".
The committee also proposed amendments to the full parliament that would strengthen the independence of a European Medicines Agency (EMEA) paediatric committee
monitoring child usage of adult pharmaceuticals.
The Commission and the Council have agreed notably to integrate amendments concerning the transparency of work and the composition of the paediatric committee
(to be established within the European Agency for the Evaluation of Medicinal Products); provisions in the event of medicinal products being withdrawn from sale; clarification of procedural deadlines; labelling of medicinal products; and clarification of rewards available to industry.a