The European Medicines Agency (EMA) has been told to accept the gagging orders of two US pharma companies pending a decision by the EU General Court.

Legal challenges by AbbVie and InterMune to the EMA’s policy of publishing clinical trial data relevant to its drug assessments must be accepted until a final judgement is made, the court said.

The US companies’ action contrasts with the growing trend in European pharma, with GSK and Roche both pledging to improve their clinical trial data transparency.

In accordance with a policy declared in 2010, the EMA is granting access to all clinical and non-clinical information (including clinical study reports) submitted by companies in their applications for marketing authorisation.

This is the first time that its policy of full disclosure of clinical trial data following the authorisation decision has been legally challenged.

The EMA is considering whether to appeal the interim decision that the AbbVie and InterMune clinical trial data cannot be made public. It has stated the need for clinical data transparency to enable scrutiny of its recommendations.

Since the filing of the two legal challenges in March, the EMA has received statements of support from the European Ombudsman, national competent authorities, members of the European Parliament, academic institutions and scientific journals.

The Agency will continue to draft its policy on clinical trial data.

Vanda Pharmaceuticals has withdrawn its application for a central marketing authorisation with the EMA for its schizophrenia drug Fanaptum (iloperidone).

The company decided to withdraw its application after it was unable to supply data requested by the EMA within a set timeframe. 

The application was originally submitted by Vanda to the EMA in June 2011. But in December 2012, the Agency’s Committee for Medicinal Products for Human Use (CHMP) failed to recommend Fanaptum for marketing authorisation.

Last month, Vanda requested that the EMA re-examine the recommendation. However, the company stated that the missing data, which the CHMP identified during its recommendation, would not be available within the timeframe acceptable in the centralised procedure. 

AbbVie is seeking a legal injunction to block the European Medicines Agency (EMA) from publishing clinical trial data relating to its rheumatoid arthritis drug Humira.

The biopharmaceutical company claims that publishing the trial data would violate both commercial confidentiality and patient confidentiality.

AbbVie’s position contrasts with that of GSK, which has committed to publishing all its future and past clinical trial data, and shows that the pharma industry is becoming polarised on this issue.

The EMA has committed to publish all clinical trial data once a drug has completed marketing authorisation from the start of 2014.

The AllTrials ‘open data’ movement, which GSK now supports, has been driven by medical authorities including the Cochrane Collaboration and the BMA.

The AllTrials position is that secrecy around clinical trial data rewards dishonesty in the planning and reporting of trials, and that transparency is in the interests of all patients and all honest pharma companies.

AbbVie, which recently split off from Abbott, has the support of the European Federation of Pharmaceutical Industries and Associations (EFPIA) in seeking to protect clinical trial data as ‘confidential’.

By preventing the EMA from publishing the clinical trial data relating to Humira (adalimumab), AbbVie seeks to ensure its own right to select which data are available to prescribers and patients.

Lundbeck’s Selincro (nalmefene) has been granted a marketing authorisation by the European Commission to reduce alcohol intake in adults with alcohol dependency.

The decision was based on the results of three pivotal trials which showed Selincro helped reduce alcohol consumption by 40% within the first month and by around 60% after six months.

Anders Gersel Pedersen, Head of Research & Development and Executive Vice President at Lundbeck, called the drug the “first major innovation in the treatment of alcohol dependence in many years.”

The authorisation applies to all 27 European Union member states. Lundbeck now expects to launch the drug in the next few months.

The tablet will be available to the patient each day when they feel at risk of drinking. Selincro will be provided as part of a novel treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence.

“The approval of Selincro is exciting news for the many patients with alcohol dependence who otherwise may not seek treatment,” said Anders Gersel Pedersen.

MSD has formally notified the EMA of its decision to withdraw the application for a centralised marketing authorisation for Jenzyl (ridaforolimus).

Jenzyl was intended to be used for as a maintenance therapy for patients with metastatic soft tissue sarcoma or bone sarcoma.

The treatment was being reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) after an application for a European marketing authorisation was submitted in June 2011.

But MSD said in its withdrawal letter that the decision was made after the CHMP considered that the data supplied did not allow it to conclude on a positive benefit-risk balance.

The FDA and the EMA are to review Biogen Idec’s marketing application for BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).

BG-12 is the only known investigational compound for the treatment of MS that has experimentally demonstrated activation of the Nrf-2 pathway.

It has demonstrated significant reductions in MS disease activity, coupled with favourable safety and tolerability in two separate Phase III clinical trials.

Last year, Biogen published data from the DEFINE and CONFIRM global clinical trials that demonstrated BG-12’s effectiveness in patients taking the treatment either twice or three times a day over a period of two years.

As a result, the FDA has now accepted Biogen’s New Drug Application and granted the company a standard review timeline. In addition, the EMA has validated a similar application for review.

The EMA’s CHMP has maintained its decision not to recommend a marketing authorisation for the orphan medicine Glybera (alipogene tiparvovec).

The Committee again reviewed the benefit risk of Glybera in lipoprotein lipase deficiency patients with severe or multiple pancreatitis attacks.

But it concluded there was insufficient evidence to show the benefit of the gene-therapy in the restricted group of patients and was unable to recommend marketing authorisation.

The European Commission requested in January 2012 that the EMA review its negative opinion confirmed in October 2011. That followed a request from the applicant Amsterdam Molecular Therapeutics B.V. after the CHMP had originally failed to recommend the marketing of the product in June 2011.

Glybera is a gene-therapy product that uses an adeno-associated viral vector intended to treat adult patients diagnosed with lipoprotein lipase deficiency demonstrating hyperchylomicronaemia or who have a history of acute pancreatitis.

But the CHMP found it difficult to obtain and assess data in this very rare disease.

After considering all of the evidence, it concluded that Glybera reduced pancreatitis attacks in the small number of patients assessed, but the evidence was not sufficiently convincing.

In addition, the Committee decided that the reduced risk of pancreatitis attacks may have been due to other factors, such as lifestyle and diet.

The European Medicines Agency (EMA) has tightened up its rules on clinical trials in order to counter the damaging effects of globalisation.

From 1 May 2012, clinical trials used to support EU marketing authorisation applications will require the informed consent of participants.

The trial protocol will also need to be submitted to an independent ethics committee before the trial takes place.

According to the EMA’s reflection paper, a trial will be disqualified if non-compliance “significantly affects the rights, safety or well-being of the subjects or the quality and integrity of the data reported”.

The EMA said these measures were necessary to address the globalisation of clinical trials: “No matter where you stand today, most clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in a different cultural setting.”

The agency said it will work to improve international co-operation on trial regulation and help regulators to gain assurance that ethical and good clinical practice standards are applied.

In recent years the pharma industry has used 178 countries for clinical trials, with China, Russia, India, Brazil, Poland and South Africa becoming key locations.

While all trials used in EU marketing authorisation applications are expected to meet the same ethical standards as trials conducted in Europe, there have been a number of alleged breaches of standards.

The case of Pfizer’s 1996 trial in Nigeria of its meningitis drug Trovan, in which 11 children died, reflects the legal complexity of such cases. Pfizer finally reached a settlement with the families involved in 2009.

This year, GSK denied claims that it failed to secure consent from the parents of children enrolled in an Argentinian study of its pneumococcal vaccine Synflorix.

Unethical overseas drug trials were the subject of a high-profile film, The Constant Gardener, based on a novel by John le Carre – who claimed that the pharma industry was guilty of worse crimes than those he had depicted.

The European Commission has granted marketing authorisation to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin in adults with type 2 diabetes who have not achieved adequate glycaemic control.

The authorisation for adults who have not responded to metformin and/or Actos follows clinical trial data which showed Byetta helped reduced glucose levels and reduce patients’ weight.

Dr Christian Weyer, Senior Vice President, R&D, Amylin Pharmaceuticals, said the decision “provides a new option” for patients who are not “achieving treatment goals”.

Byetta, the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes, has been used by more than 1.8 million patients globally since its introduction.

In the main, double-blind, 30-week clinical trials, submitted to the EC, Byetta demonstrated a statistically significant reduction of hypoglycaemia compared to placebo. Participants who added Byetta to their insulin glargine regimen also saw their weight decrease by an average of four pounds.

“In a clinical trial, patients using fixed-dose Byetta with titrated basal insulin achieved better postprandial and overall glycaemic control, without weight gain or an increased risk of hypoglycaemia, compared to patients using titrated basal insulin without Byetta,” said Dr Weyer.

The European Medicines Agency (EMA) has piloted an electronic application form for regulatory submissions from pharmaceutical companies.

The four-month pilot will enable companies to file applications for marketing authorisation using an interactive PDF form.

This represents a step towards making the use of the Electronic Common Technical Document (eCTD) standard in submissions for EMA approval.

While companies have been able to use the eCTD for submissions to the EMA since 2003, paper submissions have remained the norm due to the complexity of the electronic process.

According to the EMA, the new process will “simplify and speed up the application process” by enabling companies to submit data in XML format, improve the quality and consistency of the data, and integrate it with controlled vocabulary lists.

The new electronic application forms for human medicines are supported by Data Exchange Standards documentation, XML schema definitions and user guidance.

A second pilot will provide access to electronic forms for veterinary medicines.

The new forms were developed by the EMA in collaboration with the European Commission services and national medicines regulatory authorities in the EU.