Vanda Pharmaceuticals has withdrawn its application for a central marketing authorisation with the EMA for its schizophrenia drug Fanaptum (iloperidone).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

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.

Eisai is celebrating after The All Wales Strategic Medical Group (AWSMG) and Scottish Medicines Consortium (SMC) backed a drinkable version of Inovelon (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS).

The oral suspension can be used in children aged four and over who have failed treatment with, or are intolerant of, other antiepileptic drugs.

Mike Bee, Epilepsy Business Unit Director, EU North, Eisai, said approval of the medication was important to “help address the adherence needs of children and young people.”

LGS is a severe form of epilepsy which accounts for between 5%-10% of childhood cases.

The decision to approve the treatment follows the approval of the tablet formulation by both authorities in 2008. That approval was based on data which showed Inovelon can significantly reduce the frequency of total and tonic-atonic seizures and improve seizure severity.

The oral alternative was shown to be bioequivalent and cost-effective in Scotland and Wales.

Inovelon – in an oral form – received positive CHMP opinion in September last year and was granted EMA approval in November 2011. It was launched in the US in March 2011 marketed as Banzel.

Eisai has received recommendations from the European Medicines Agency (EMA) for two of its portfolio of anti-epilepsy drugs (AEDs).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the use of Zonegran (zonisamide) to a monotherapy for partial seizures in adults with newly diagnosed epilepsy.

It has also recommended the use of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures in patients with epilepsy aged 12 or older.

Epilepsy is a chronic brain disorder that affects an estimated six million people in Europe, and AEDs are a major strategic focus for Eisai in this market.

The recommendation of Zonegran as a monotherapy is important because patients with newly diagnosed epilepsy find combination therapies particularly difficult to tolerate.

Michel Baulac, Head of the Clinical Department at the Hospital de la Pitie-Salpetriere, Paris, France, said: “Monotherapy remains the optimal approach for managing patients with epilepsy. In addition to a good tolerability profile and to the absence of interaction with other drugs, in particular with oral contraceptives, zonisamide offers the added value of a once-daily dosing.”

Fycompa is a new option for the management of partial-onset epilepsy, as it selectively blocks a particular type of seizure-inducing neurotransmission.

“Improving seizure control is one of the most pressing unmet needs in epilepsy patients,” commented Professor Bernhard Steinhoff, Medical Director of the Epilepsy Center at Kehl-Kork, Germany. “Perampanel will be a completely new option for the adjunctive treatment of patients with uncontrolled seizures.”

The European Medicines Agency (EMA) has requested a label update to provide clearer guidance on the safe use of the anticoagulant Pradaxa (dabigatran).

The review has confirmed the drug’s positive benefit-risk balance as a stroke prevention treatment for certain patients, but stated the need for clearer notes on the medicine’s risks and what to do in case of bleeding.

The Boehringer Ingelheim drug is recommended for patients with non-valvular atrial fibrillation or following hip or knee replacement.

Because all blood-thinning drugs can cause bleeding, the EMA has maintained close post-market surveillance of this product.

The EMA’s scientific advisory committee, the CHMP, found that the incidence of fatal bleedings with Pradaxa in post-marketing data was significantly lower than in the clinical trials that led to the drug’s authorisation in 2008.

In November 2011, a safety review concluded that the drug should be used with caution, and at lower doses, with patients who were elderly or had moderate renal impairment.

Pradaxa “remains an important alternative to other blood-thinning agents,” the EMA said.

However, the guidance for doctors and patients should be strengthened to include details of the risks, when the drug must not be used, and how to manage patients if bleeding occurs.

In particular, patients taking Pradaxa should seek urgent medical attention of they fall or suffer any injury.

The European Commission is expected to confirm this opinion.

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 CHMP has approved Novartis’ Jakavi (INC424, ruxolitinib) for the rare conditions of adults with myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

The recommendation was based on findings from the COMFORT clinical trials which demonstrated Jakavi to improve overall survival rates and reduce spleen volume compared to placebo.

Hervé Hoppenot, President, Novartis Oncology, said the oral inhibitor “may address unmet patient needs”.

The CHMP’s opinion has now been passed on to the European Commission (EC) to deliver a final decision. The EC has previously granted Jakavi orphan drug designation for myelofibrosis.

Currently, there are only a handful of treatments available to treat the life-threatening blood cancer disease. Myelofibrosis is characterised by multiple severe complications including bone marrow failure, an enlarged spleen and shortened survival.

Myelofibrosis affects around 0.75 out of 100,000 people each year in Europe. Studies have shown that patients with the disease have a decreased life expectancy with a median survival of 5.7 years.

In the COMFORT-I trial, almost half (41.9%) of patients treated with Jakavi achieved at least a 35% reduction in spleen volume at 24 weeks compared to just 0.7% of patients in the placebo group.

In the COMFORT-II trial, the treatment produced a reduction in spleen volume of greater than 35% in 28.5% of patients compared with 0% of patients in the best available therapy – or not therapy at all – group at 48 weeks.

Results also showed how continuous use of the therapy provided a marked and durable improvement in overall quality of life at 48 weeks.

“The Committee’s positive opinion today validates the strong data in support of Jakavi and the very high unmet need in treating myelofibrosis,” said Hervé Hoppenot.

“The recommendation for European Commission approval of Jakavi also marks a significant step forward in bringing the first and only JAK 1 and JAK 2 inhibitor to patients with very limited options.”

A decision is now expected from the EC within the next three months.

Multiple sclerosis (MS) treatment Gilenya (fingolimod) has had its prescribing information updated after discussions with the EMA and the FDA.

Novartis has agreed to the updates to provide healthcare professionals with further guidance on initiating its use in patients with MS after reviews by both health regulators following cardiovascular concerns in certain patients.

Patients starting the use of Gilenya should have an electrocardiogram (ECG) and blood pressure measurement prior to the first dose with regular updates and continuous ECG monitoring for a minimum of six hours afterwards.

The CHMP has now confirmed a positive benefit-risk profile for the once-daily oral medication following the label change.

“We believe that Gilenya is a valuable treatment option for many patients with relapsing-remitting MS, and we welcome the confirmation of the positive benefit-risk profile of the drug which also supports our continued belief of the blockbuster potential of Gilenya,” said David Epstein, Division Head of Novartis Pharmaceuticals.

In additional, the label update in the EU also cautions against Gilenya’s use in patients who may be less tolerant of it or are more likely to develop a significantly slowed or abnormal heart rate because of certain underlying conditions or concomitant medications.

In the EU, Gileyna is approved for people with highly active relapsing-remitting MS despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS.

The CHMP’s labelling recommendations will be reviewed by the European Commission with a final decision expected in June 2012.

The Chair of the European Medicines Agency’s committee for approving new drugs has resigned suddenly with immediate effect.

Dr Eric Abadie, who has led the Committee for Medicinal Products for Human Use (CHMP) since 2007, stood down after his position at the French healthcare regulator AFSSAPS was questioned.

The regulator has come under scrutiny for allowing the continued sale of Mediator after it had been withdrawn for safety reasons elsewhere.

Concerns have also been raised about the Agency following the controversy over breast implants manufactured by French firm PIP.

Dr Abadie noted in his public declaration of interests with the EMA that he had no links to any pharmaceutical company or health organisation. However, a spokesman said his decision was related to his position at the AFSSAPS, where he works as a scientific advisor to its Director General.

A spokesperson for the EMA said an election for a new chair for the CHMP would happen in “due course”.

In the meantime, Dr Tomas Salmonson, currently the vice-chair of the CHMP, will lead the Committee to ensure a continuity of operations. The next meeting is scheduled for April 16-19.

Astellas Pharma Europe B.V. has formally withdrawn its application to extend the indication of Qutenza (capsaicin).

An application was submitted in May 2011 to extend the marketing authorisation for the pain relief patch to all adult patients, with the exception of patients with pain resulting from diabetes.

However, Astellas formally notified the EMA of its withdrawal after the CHMP decided that the data supplied did not allow it to conclude a positive benefit-risk balance for the medication.

Qutenza was first authorised for use in the European Union in May 2009. It is currently indicated for treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medication.