European Regulatory Roundup: Roche Awaits Outcome of Pharmacovigilance Infringement Procedure (7 July 2016)

Regulatory NewsRegulatory News | 07 July 2016 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA Proposes Revised Guideline on Development of Axial Spondyloarthritis Drugs

The European Medicines Agency (EMA) has released a revised guideline on clinical development of treatments for axial spondyloarthritis for consultation. EMA is proposing the revisions to bring the text in line with the evolution in clinical practice since it published its original guideline in 2009.

Specifically, EMA wants the text to reflect the emergence of the classification “non-radiographic axial spondyloarthritis.” This term categorizes patients with the chronic inflammatory disease axial spondyloarthritis who do not meet the criteria for ankylosing spondylitis as set out in the modified New York rating, but nonetheless have disease activity and functional impairment comparable to people with the latter condition. EMA has addressed the specific needs of this subpopulation of axial spondyloarthritis patients in its revised guideline.

The guideline calls for treatments for axial spondyloarthritis to demonstrate efficacy in both patients with the non-radiographic form of the disease and those who meet the criteria needed to be diagnosed with ankylosing spondylitis. As such, EMA is proposing that clinical trial sponsors enroll patients with both conditions in sufficient numbers that sub-group analyses are possible. One goal of these analyses is to demonstrate that the response of the subgroups to the treatment is consistent with the overall outcome.

To perform such analyses, sponsors first have to know the status of the patients they enroll. The 2009 Assessment of SpondyloArthritis International Society criteria that defined the non-radiographic form of the condition are validated for the selection of patients in clinical trials, but EMA is concerned by the high rate of false positives that are generated when using this tool in certain populations. EMA is open to sponsors enforcing additional restrictions on inclusion, such as the presence of “objective signs of inflammation” at the time of enrollment.

Officials have also used the revision of the guideline as an opportunity to propose new outcome measures and tweak their advice on the design of confirmatory trials. EMA is proposing the trial design amendments in response to changes to the list of treatments that are available for people with the condition. With products such as anti-TNFs now available, EMA is suggesting sponsors include an active comparator arm in their trials. This will allow the regulator to assess the risk-benefit balance of experimental products against those of existing treatment options.  

Draft Guideline

Roche Awaits Outcome of Pharmacovigilance Infringement Procedure

EMA has concluded its second investigation into pharmacovigilance practices at Roche, moving the case closer to the day the Swiss pharma will find out whether it will be punished for infringements. The case dates back to the identification of “serious shortcomings” at Roche in 2012.

After almost four years and two investigations, EMA has now once again submitted its findings to the European Commission (EC). The report filed by EMA this month will form the basis of the EC’s ruling on whether or not to pursue the case against Roche further, a procedure that could lead it to impose financial penalties against the company. The EC is yet to say how long it will take it to reach a decision on the matter.

The process has already dragged on for several years. Roche first became the focus of an EMA probe late in 2012 after a pharmacovigilance inspection by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) uncovered “serious shortcomings” with its processes. That first EMA investigation sent a report to the EC, Roche and member states in April 2014. However, the EC returned the case to EMA in July 2015 and asked it to open a new inquiry.

EC officials requested the follow-up investigation so EMA could take a deeper look at certain details. With that process out of the way, Roche is now once again awaiting the judgement of the EC.  

EMA Statement

EMA’s Paediatric Committee to Communicate Opinions Electronically From August

The Paediatric Committee (PDCO) at EMA is to switch to electronic communication on 1 August. As of that date, all PDCO opinions and subsequent EMA decisions will be transmitted electronically unless applicants request to receive hard copies.

PDCO will communicate via EudraLink, the file-transfer system that covers the European regulatory network. For applicants, this means they will receive opinions and decisions in PDF files. EudraLink will record when the message delivering the PDF is opened. This will become the date of receipt for the purpose of calculating procedural timelines associated with regulatory actions regarding pediatric medicines.

EMA said the change was motivated by feedback from the industry and a belief that switching to electronic delivery will convey some benefits to applicants. The regulator anticipates the use of PDFs will accelerate the delivery of files, be more convenient for users and further its environmental agenda. In recent years, EMA has moved multiple aspects of its regulatory machinery online in an attempt to realize these benefits.  

The PDCO switch does place some additional requirements on applicants, though. EudraLink only stores file attachments for 90 days, meaning companies receiving opinions and decisions through the system must get into the habit of downloading and archiving the PDFs they receive. EMA only stores read-only versions of electronic documents in its archives. Applicants should also be aware that the opinions and decisions sent electronically will lack a signature.

Organizations that would prefer to continue receiving hard copies can request to opt out of the new electronic model. 

EMA Notice

AstraZeneca, Genzyme Chided by PMCPA Over Breaches of Promotion Code

The Prescription Medicines Code of Practice Authority (PMCPA) has found fault with promotional activities at AstraZeneca and Genzyme. PMCPA, a British self-regulatory body, chided AstraZeneca for providing misleading instructions and Genzyme for disparaging a rival product.   

Genzyme was the subject of the more severe of the two PMCPA responses. PMCPA ruled the big biotech had breached 11 clauses in its code of conduct, including “bringing discredit upon, and reducing confidence in, the pharmaceutical industry.” Genzyme was found to have breached this significant clause in materials it released in 2014 to compare its Fabrazyme to Shire’s Replagal. The PMCPA felt the materials were misleading and disparaging.

In comparison to Genzyme’s case, the clauses breached by AstraZeneca were minor. PMCPA ruled the company breached three clauses for producing material that could have led to patients being inappropriately treated with the diabetes drug Forxiga. The material was deemed to have made claims that were both misleading and inconsistent with the summary of product characteristics.  

PMCPA Notice

Other News:

The United Kingdom has officially closed its program. Officials set up the scheme to facilitate the sharing of healthcare data with drug developers and other organizations, but public concerns about the program prompted the government to delay its implementation. Now, following a review into what went wrong, NHS England has decided to close Government Statement

MHRA has issued a warning regarding TRUEyou blood glucose tests strips. The warning follows reports that an issue with the packaging processes has resulted in some batches giving false low blood glucose results. MHRA is concerned these inaccurate readings could result in hyperglycemia going undetected. The regulator is asking people with affected lots to discontinue use. MHRA Notice

EMA has shared an update about its ongoing attempts to tighten its ties to academia. EMA Statement



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