The European Network of Pediatric Research at the European Medicines Agency will hold its ninth annual workshop on 16 May 2017 in London, UK. The main objective of the workshop is to bring important stakeholders together to discuss necessities, hurdles and prospects for high-quality clinical studies in children.

Among the highlights of this year’s workshop are the current struggles to maximize collaboration between the European Union and the United States to facilitate global pediatric trials and medicine developments.

The first day of the workshop will be open to all stakeholders comprising:

• Patients/parents
• Organizations,
• Regulators
• Enpr-EMA network representatives
• Academia
• Clinical investigators and representatives from the pharmaceutical industry for pediatric studies.

Participants will hear about Enpr-EMA’s activities to substitute high-quality research in pediatric medicine and will be invited to share their views on the successes made so far and the way forward.

Registration for the first day of the workshop is open until 28 April 2017.

The second day of the workshop is kept for discussions among the members of Enpr-EMA and the Enpr-EMA organizing group. The organizing group will define significances for 2017-2018 based on the feedback received from stakeholders.

Enpr-EMA was set up to help the conduct of clinical studies in children. It is an umbrella network of 39 national and international networks known for their experience in pediatric research. It acts as a platform for sharing good practices.

Dated :9^TH Feb 2017

The European Medicines Agency (EMA) has published clinical data for two further medicines on its clinical data website. This leads to the launch of the website on 20 October 2016 and is in link with the Agency’s policy on the publication of clinical data.

These are the first clinical data published supporting an application that was consequently reserved. The clinical data for Aripiprazole Mylan relate to a withdrawn application for a marketing approval for a generic product to treat schizophrenia, and to stop and treat moderate to severe manic episodes in patients with bipolar I disorder.

Palonosetron Hospira is a generic product designated to stop nausea and vomiting initiated by chemotherapy.

Both medicines have been evaluated mentioning to information available on the effectiveness and protection of their active materials present in the respective sanctioned ‘reference medicines’. For more information on generic medicines see Questions and answers on generic medicines.

In future, the Agency will publicize clinical data publication under this policy on its commercial website on a case-by-case basis only. EMA will continue to highlight the publication of new clinical data on its clinical data website.

Dated: 1^st Feb 2017

The European Medicines Agency (EMA) has suggested that medicines comprising a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can remain to be used to treat acne when proper treatments applied to the skin or antibiotics taken by mouth have not worked. However, these medicines, which are also permitted as hormonal contraceptives, should only be used in women who choose oral contraception.

Having evaluated the existing data on the effectiveness of the combination in the treatment of acne, EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that there is adequate proof to sustenance its use in moderate acne. Regarding the threat of side effects, the CHMP measured that the available data do not raise any new safety concern. The known risk of venous thromboembolism (VTE or blood clots in veins), which can occur with all combined hormonal contraceptives, is considered low. However, the data on the risk with dienogest/ethinylestradiol are not adequate to assess how it compares with other contraceptives and further data are still awaited.

As the detected benefits of dienogest/ethinylestradiol in the treatment of acne, the potential risk of VTE and the nature of the disease, the CHMP concluded that this combination should only be used after certain other treatments have failed, and only when oral contraception is chosen. The CHMP also recommended that women should be evaluated by their doctor 3 to 6 months after starting treatment and periodically subsequently to review the need for continuation of treatment.

27th Jan 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/01/news_detail_002685.jsp&mid=WC0b01ac058004d5c1

European regulators are active to give a quick review of AbbVie’s investigational, pan-genotypic procedure of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the cure of chronic hepatitis C (HCV) in all major genotypes.

According to the firm, the G/P procedure could deliver a shorter, eight week, once-daily, ribavirin-free cure option for the preponderance of HCV patients without cirrhosis and a supplementary treatment alternative to patients with compensated cirrhosis (Child-Pugh A).

The treatment is also projected to look forward the needs of patients with detailed treatment trials, such as those with severe chronic kidney disease (CKD) and those not treated with previous direct-acting antiviral (DAA) treatment.

The application comprises data from eight registrational studies in AbbVie’s G/P clinical growth programme, concerning more than 2,300 patients across all main HCV genotypes and special populations, which was intended to consider a faster path to virologic cure for all foremost genotypes and with the aim of covering areas of sustained unmet need.

According to AbbVie’s chief scientific officer Michael Severino,”We are contented at the prospective of our investigational, pan-genotypic regimen and that it has been approved enhanced valuation by the EMA. We will work closely with the EMA as we continue our assurance to possibly offer a treatment for as many people living with HCV as possible”.

Date: 24th January 2017

http://www.pharmatimes.com/news/speedy_eu_review_for_abbvies_pan-genotypic_hep_c_therapy_1184944

Provisional marketing authorization (CMA) can speed up access to medicines for patients with unmet medical needs. Since 2006, a total of 30 medicines have received a provisional marketing authorization. Medicines that were approved a CMA target seriously enervating or life-threatening conditions such as HIV infection, breast cancer, and severe epilepsy in infants or multi-drug resistant tuberculosis. 14 were orphan medicines, providing patients suffering from rare diseases with new treatment options. These are some of the findings of a report by the European Medicines Agency (EMA) to mark ten years of experience with CMA.

EMA’s report is a wide-ranging investigation of the positive influence this important tool has had in providing early access to new medicines for patients who formerly had no or only substandard treatment options. It emphases on how CMAs are approved or rejected and later converted into normal marketing authorizations. It also examines the type, extent and timing of data provided to support these decisions.

Provisional marketing authorization is one of the implements available to regulators to support the growth of and early access to medicines that address unmet medical needs of patients in the European Union (EU). It permits the approval of medicines if the public health assistance of their immediate availability to patients outweighs the risk of an authorization on the basis of less inclusive data than normally required. Over a period of 10 years, no medicine with a CMA had to be repealed or adjourned.

A CMA is effective for one year. As part of the authorization, the company is indulged to carry out further studies to obtain complete data. EMA’s Committee for Medicinal Products for Human Use (CHMP) evaluates the data generated by these specific post-authorizations requirements at least annually to guarantee that the balance of benefits and risks of the medicine remains positive. At the end of its valuation, the Committee recommends either the renewal or not of the CMA or its alteration into a standard marketing authorizations.

According to EMA’s analysis, marketing authorizations holders comply with the specific responsibilities forced by the Agency. More than 90% of completed precise responsibilities did not result in major changes of scope and about 70% of specific obligations did not need an extension to the initially stated timelines.

The report shows that it took an average of four years to generate the additional data needed and to convert a CMA into a full marketing authorization. This means that patients with life-threatening or seriously incapacitating conditions can access promising medicines earlier.

The report also personifies the data on which CMAs have been granted and the additional data generated through specific obligations. This information could be of interest for those developing medicinal products, as well as patients, pricing and reimbursement bodies and other stakeholders.

The report also categorizes a number of possible areas for expansion. These comprise:

• future planning of CMAs and early dialogue with EMA to support the generation of high-quality data, timely discussion of additional post-authorization studies and their possibility, and better data generation for accomplishment of explicit obligations;
• Appealing other stakeholders involved in bringing a medicine to patients, in particular Health Technology Assessment bodies, to help the generation of all data needed for decision-making through one development programme.

The full report is available together with an infographic that highlights the important results of this study. The publication of EMA’s report emphasizes the Agency’s commitment to transparency.

It responds to discussions in the European Commission’s expert group on Safe and Timely Access to Medicines for Patients (STAMP), which emphasized interest in accepting the experience of conditional marketing approvals in the EU.

Date:23 Jan, 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/01/news_detail_002680.jsp&mid=WC0b01ac058004d5c1