Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 29 September 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
AstraZeneca has withdrawn its EMA marketing authorization application for cediranib in a subset of ovarian cancer patients. The company took the action after running into “differences of opinion” with EMA about the side effects of the drug and the way the study was run, The Telegraph reports.
A spokesman for AstraZeneca told the British newspaper that, despite having the Medical Research Council (MRC) team that ran the study talk to EMA, it was unable to win the regulator over on its way of thinking. AstraZeneca had hoped MRC could allay EMA’s concerns about the methods and analysis used in the trial.
“We went back and forth but sometimes you just can’t change someone’s mind,” the spokesman said. “If you have a difference of opinion, you have to take a view as to where it is going to go.”
EMA’s concerns reportedly extended beyond the design of the trial. Specifically, AstraZeneca said the regulator questioned whether the benefits provided by the drug to patients with platinum-sensitive relapsed ovarian cancer outweigh the diarrhea, fatigue and other side effects seen in the study.
Press Release, The Telegraph
The National Institute for Health and Care Excellence (NICE) has reversed its position on Alexion Pharmaceuticals’ hypophosphatasia drug, Stensiq. Having previously said Alexion had failed to justify the product’s approximately $500,000-a-year price tag, the United Kingdom cost watchdog has now backed the use of the drug in certain types of hypophosphatasia.
NICE’a latest evaluation consultation document supports the use of Stensiq in patients with perinatal and infantile-onset forms of hypophosphatasia, as long as Alexion “provides opportunities to reduce the short-term cost.” The decision only amounts to a partial climbdown by the watchdog. Notably, NICE is still refusing to recommend the use of Stensiq in juvenile-onset hypophosphatasia, a form of the rare vitamin B6 deficiency that is more common and less likely to be fatal than the variants that take hold during the first six months of life.
The watchdog reached that decision despite acknowledging Stensiq, also known as asfotase alfa, “would be associated with a significant [quality-adjusted life-year] gain.” For NICE, the issue is that the medical need of people with the juvenile form of the disease varies significantly, and it has little confidence in Alexion’s ability to identify who will benefit most. When paired to uncertainties about the size of the patient population, NICE concluded Stensiq “could put a considerable financial burden on the [National Health Service],” potentially hindering its ability to pay for other treatments.
Given NICE’s initial unwillingness to countenance paying for Stensiq, the partial U-turn still represents a victory for Alexion, which had a similar second-attempt success in the UK with another of its rare disease drugs, Soliris.
NICE was rather quicker to recommend Epclusa, the latest combination drug to emerge from Gilead Sciences’ hepatitis C franchise. The product combines the active ingredient in Sovaldi with another drug, resulting in a therapeutic designed to treat all genotypes of hepatitis C. NICE made its recommendation after securing an undisclosed discount to the product’s £38,980 ($56,690)-a-course sticker price.
NICE Consultation, More
The Committee for Medicinal Products for Veterinary Use (CVMP) has begun the process of revising its 18-year-old guidance on adjuvanted vaccines for use in animals. CVMP thinks an update is needed to reflect advances in regulatory understanding of new and classical adjuvants, specifically by revising the criteria for benefit-risk assessments and data requirements for marketing applications.
Members of CVMP’s Immunologicals Working Party (IWP) have made the case for change in a draft concept paper. As IWP sees it, the veterinary vaccine industry has developed adjuvants that induce less local and general reactions in animals since the current guidance was released in 1998. Yet, in the absence of updated regulatory advice on adjuvants in veterinary vaccines, manufacturers have shied away from including them in their products. Veterinary vaccine developers reportedly think the current guidance is “inadequate” with regard to new substances.
The European Medicines Agency’s (EMA) CVMP wants to change this perception by introducing new guidelines. Specifically, CVMP plans to update details of the quality, safety and efficacy testing adjuvant-enhanced vaccines must undergo, and the type of data sponsors must include in marketing authorization applications. Other topics on CVMP’s radar entering into the revision process include considerations relating to the use of adjuvants in certain species, the maximum residue limits for adjuvants in food-producing animals and the use of adjuvants in non-vaccine immunological drugs.
CVMP has given the veterinary vaccine industry and its regulatory peers until the end of the year to comment on the draft concept paper. Once the feedback is in, IWP plans to schedule a meeting for February to discuss the next steps. If everything goes to plan, CVMP will have a revised draft guideline ready to release for consultation in the fourth quarter of next year, setting it up to adopt a new final guideline late in 2018.
The regulator has set itself a similar timeline for the revision of guidelines on multi-strain dossiers for inactivated vaccines against avian influenza, bluetongue and foot-and-mouth disease. CVMP released a draft concept paper to begin that revision process alongside the adjuvant text. The concept paper is a response to the real-world lessons CVMP has gained since introducing the existing document in 2009. Notably, while the guideline has successfully supported the development of vaccines against foot-and-mouth disease, it appears ill-suited to the complexity of bluetongue vaccines.
CVMP also published a reflection paper on the risks of using unauthorized vaccines in emergency situations.
Concept Paper, Reflection Paper, More
EMA’s Healthcare Professionals Working Party (HCPWP) has re-elected Gonzalo Calvo for a second three-year term as co-chair. The appointment gives Calvo an important role at HCPWP at a time when EMA is taking steps to ensure healthcare professionals have a voice in the regulatory process.
Earlier this year, EMA held a workshop with general practitioners and family doctors to discuss their role in the regulatory process, leading to the creation of an expert group that will act as a bridge between the groups. This move continued the trend for healthcare professionals to play a more active role in the work of EMA.
Calvo has been involved in some of these initiatives in his capacity as co-chair, but, with a second three-year team now in front of him, the Spanish physician thinks there is still more work to do.
“My aim is to consolidate the work initiated and open new paths to strengthen the role and impact of healthcare professionals in regulatory activities, securing fast and safe access to new medicines,” Calvo said.
While HCPWP elected Calvo, the Patients' and Consumers' Working Party (PCWP) is yet to fill the same position at its group. “A conclusion on the election of its new co-chair was not reached during this meeting,” EMA said.
Tags: AstraZeneca, Alexion, Strensiq, PCWP