European Regulatory Roundup: 23andMe, Scorned by FDA, Comes to the UK (4 December 2014)

Regulatory NewsRegulatory News | 04 December 2014 |  By 

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

23andMe Wins Regulatory Clearance to Sell DNA Test Health Reports in UK

23andMe has started selling its DNA tests and accompanying health reports in the United Kingdom after receiving clearance from regulators. European authorities awarded the test a CE Mark and a UK Research Ethics Committee approved it for sale.

The regulatory approvals give 23andMe a boost at a time when it is still working to resolve the FDA warning letter it received one year ago. However, the European decisions fall short of being a rebuttal of FDA’s concerns. European regulations for tests are less onerous than those imposed in the US and the product sold by 23andMe has undergone some changes since it was chastised by FDA.

People who pay £125 ($196) for the test will receive a report listing their genetic risk factors for various diseases — which 23andMe is now unable to provide in the US — but it has been pared down for the UK market. “Many of the drug responses, inherited conditions and genetic health risks that were of concern in the US have been removed,” a Department of Health representative told BBC News.

BBC NewsI GenomeWebI Press Release

Italy Confirms Safety of Novartis Flu Vaccine After Patient Deaths

The Italian AIFA and EMA's Pharmacovigilance Risk Assessment Committee (PRAC) have both dismissed the possibility that Novartis’ flu vaccine Fluad caused the deaths of around 16 people. Late last week, AIFA suspended two batches of Fluad following reports people had died after taking the vaccine, but testing found nothing wrong with the suspected products.

Italian authorities quashed the alarm within days of it starting. The deaths of several people who had recently received the vaccine sparked the concerns. Once the deaths became public, the number of reported possible adverse events escalated quickly.

However, AIFA tests on the batches came back “completely negative,” leading the regulator to conclude heightened media scrutiny caused people to mistakenly assume the vaccine was responsible for unrelated deaths. PRAC’s tests also deemed the vaccine safe.

AIFA has taken action against Fluad in the past. In 2012, the Italian regulator suspended use of Fluad after particles were found in vials of the vaccine. Novartis’ Agrippal, Influpozzi and adjuvanted Influpozzi were also caught up in the 2012 quality scare. 

FierceVaccines I Reuters I EMA Statement 

EMA Releases Final Guidance on Development of Modified Release Forms

EMA has published final guidelines on the pharmacokinetic and clinical evaluation of modified release dosage forms. The regulator has made some changes to the earlier draft, such as the expansion of a section on transdermal drug delivery systems to cover factors specific to elderly patients.

The scope of the text is unchanged from the draft EMA released for consultation in March 2013. EMA has broken the text down into sections covering the development of modified release forms of new chemical entities and approved drugs with a different release rate. The guidelines also cover the abbreviated process for developing a product for which a modified release form is already approved. 

EMA has made some tweaks to the earlier draft. Developers are now advised to consider the specific skin conditions of the elderly when developing transdermal patches. EMA also now warns companies of the risk of medication errors posed by invisible patches. 

EMA Guidelines I Draft

Court Upholds Antitrust Ruling Against Novartis and Roche

An Italian regional court has delivered a blow to Novartis and Roche’s hopes of overturning a ruling that they colluded on the availability of certain drugs. The Swiss drugmakers plan to appeal the latest verdict, Reuters reports.

The case relates to a ruling by the Italian Competition Authority in March. Novartis and Roche were fined €182.5 million ($226 million) for allegedly colluding on the availability of Lucentis and Avastin. Some physicians use Roche’s Avastin off label to treat the eye diseases targeted by Lucentis, a more expensive drug.

Novartis and Roche are being pursued by the Italian health ministry for €1.2 billion in damages. Both companies deny any wrongdoing and plan to appeal the decision of the Italian regional court.


EMA Proposes Changing TB Clinical Trial Guidance in Light of Scientific Advances

EMA has released a concept paper outlining proposed changes to guidelines on clinical development of mycobacterium tuberculosis drugs. The regulator decided to rethink its approach after advances in preclinical pharmacokinetic/pharmacodynamic (PK/PD) assessments rendered some of its advice obsolete.

The PK/PD advances relate to the hollow fiber system qualified by the Committee for Medicinal Products for Human Use (CHMP) last month. EMA thinks the use of the approach necessitates the updating of its guidance on dose selection. The regulator also wants to tailor its guidance to the new, shorter treatment regimens drug developers are pursuing.

CHMP is seeking feedback on these and other topics before it starts to revise the text. The comment period is open until 28 February 2015.

Concept Paper

EMA Posts Draft Labels for Cyclodextrins and Propylene Glycol as Excipients

The European Medicines Agency (EMA) has published two draft labels and question and answer (Q&A) documents as part of a project to update its public stance on certain excipients. EMA began the project in 2011 and has now posted its latest thinking on the use of cyclodextrins and propylene glycol as excipients.

While EMA is confident few of the safety concerns relating to either excipient pose a threat to health in real-world use, it is proposing expanding the labels of both cyclodextrins and propylene glycol. Currently, products containing cyclodextrins contain no information about the safety of the excipient.

EMA is proposing to create a label that warns consumers of the risk cyclodextrins can cause irritation, diarrhea and issues for people with kidney disease. The proposed label also warns consumers and physicians to think carefully before giving drugs made with the excipient to children under two years of age.

Products containing propylene glycol already come with a brief safety label relating to the excipient. EMA is planning to expand the label with stronger warnings about high doses, as well as advice on its use at much lower levels in infants and newborns. The consultation ends in February.

Cyclodextrins Q&A I Propylene Glycol Q&A

Other News:

EMA has held a meeting to discuss what to do now that a court has annulled the appointment of Guido Rasi as executive director. The next steps are to look at how Rasi can help EMA over the coming months and begin recruiting his successor. It is unclear whether EMA would consider Rasi for the post if he were to apply. Regulatory Focus

Kent Pharmaceuticals has warned British healthcare professionals of a carton labeling mistake on the heparin it distributes for Fannin. All batches distributed since 12 November incorrectly state the product is preservative-free. To maintain supply, Kent will continue to ship affected cartons until corrected stock is available early next year. Drug Alert

European authorities have awarded CE Marks to Hologic, AcelRx Pharmaceuticals and iRhythm Technologies. The CE Marks cover Hologic’s Aptima HIV-1 Quant Dx assay, AcelRx’s Zalviso and iRhythm’s ZIO Service. Hologic IAcelRx I iRhythm

German regulators have banned Ranbaxy from shipping the antibiotic cephalosporin to the country. The decision follows a June inspection of Ranbaxy’s plant in Dewas, India, during which the regulator found fault with the sterilization of equipment. Reuters

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has shared a medical device field safety notice from Vygon. The warning relates to manufacturing errors affecting the length of the catheter and number of lumens. Field Safety Notice


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