European Commission

CROs opt for computer model techniques to test cosmetics as ban on animal testing comes into effect

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India’s pre-clinical contract research organisations (CROs) like Bioneeds, Advinus Therapeutics, Syngene and Jai Research Foundation are now looking at non-animal tests like the in-vitro analysis and even considering the advanced computer modelling techniques which are far more reliable to deliver human-relevant results in a day, unlike some animal tests that require a few weeks.

With the prohibition of the animal testing by the Union government and the revision of the Drugs and Cosmetics Rules 1945 inserting a new rule after 148-B with 148-C to forbid animal testing for cosmetics, research institutes like the IISc, NCBS and JNCASR point out that globally sophisticated computer models which accurately predict drug reactions, techniques like the 3-dimensional human cell derived skin model, quantitative structure activity relationships (QSARs) help to replace the use of guinea pigs or mice generating accurate allergic response data.

The departments of pharmacology in international universities have preferred the computerised human-patient simulators to indicate the adverse drug reactions. India with its scientific prowess and research capability could easily adopt the same, stated IISc, NCBS and JNCASR.

Bengaluru-based Bioneeds India, an OECD GLP Certified Pre-Clinical CRO, has already adhered to the European Commission’s Scientific Committee on Consumer Safety (SCCS) SCCS/1297/10 issued on 8 December, 2009 which mandates use of validated alternative methods in toxicological testing. These are Local Lymph node assay, NRU Photo toxicity, Bovine Corneal Opacity Study (BCOP), Dermal percutaneous absorption study (rHES), Direct Peptide Reactivity Assay (DPRA) and In vitro dermal irritation study (Epiderm).

“We anticipated this some time back following the EU directives and finally the Indian government has also taken a stand to implement and passing the message to the global regulators that; India is on par with the ‘Be Cruelty-Free Campaign’. Our scientific personnel are armed with the know-how for in-vitro tests and have pioneered in standardizing and implementing the same. In fact, we are one among the premier CROs in the country to comply with global regulatory guidelines of the European Commission’s SCCS which is still in the preliminary stage of implementation in India,” Dr. SN Vinaya Babu, managing director & chief executive officer, Bioneeds India Private Limited, told Pharmabiz.

However, it would have been better if this decision to ban animal studies for cosmetics becomes a global mandate. India, China and South East Asia are seen as hubs by the US and European Union for pre-clinical research. With the revival of the global economy, there would be a number of opportunities for companies in the region. Therefore adherence to SCCS norms are the need of the hour to grab some of the potential business opportunities, said Dr Babu.

Source: PharmaBiz


EMA recommends conditional marketing authorisation for Translarna to treat Duchenne muscular dystrophy

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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a conditional marketing authorisation for Translarna (ataluren), an orphan-designated medicine for the treatment of Duchenne muscular dystrophy caused by nonsense mutations. Translarna is to be used in patients aged five years and older who are able to walk.

Duchenne muscular dystrophy is a genetic disease that gradually causes weakness and loss of muscle function. Patients with the condition lack normal dystrophin, a protein found in muscles. Because this protein helps to protect muscles from injury as muscles contract and relax, in patients with the disease the muscles become damaged and eventually stop working. There are currently no approved therapies available for this life-threatening condition and the current management of the disease is based on prevention and management of complications.

In the European Union (EU), approximately 18,600 people have Duchenne muscular dystrophy. The disease can be caused by a number of genetic abnormalities. Translarna is for use in the subgroup of patients whose disease is due to the presence of certain defects (called nonsense mutations) in the dystrophin gene, which prematurely stop the production of a normal dystrophin protein, leading to a shortened dystrophin protein that does not function properly. Translarna is thought to work in these patients by enabling the protein-making apparatus in cells to skip over the defect, allowing the cells to produce a functional dystrophin protein.

In January 2014, the CHMP originally adopted a negative opinion for Translarna, but at the request of the applicant, the CHMP started a re-examination of its opinion. Following careful consideration of all available evidence, including a re-analysis of the clinical data submitted by the company, the Committee concluded that the data available are sufficient to recommend a conditional marketing authorisation. Under the terms of the authorisation, the company will be required to provide comprehensive data from an ongoing confirmatory study.

Conditional marketing authorisation is an early access mechanism which allows the Agency to recommend marketing authorisation for medicines that address an unmet medical need for patients suffering from life-threatening diseases even if comprehensive clinical data are not yet available.

The applicant for Translarna is PTC Therapeutics Limited. The company is registered as a micro-, small- or medium-sized-enterprise (SME), and as such benefited from support and incentives offered by the Agency’s SME office.

Because Translarna has an orphan designation, the Agency provided free scientific advice to the applicant during the development of the medicine. Orphan designation and the associated incentives, such as free scientific advice or ‘protocol assistance’, are among the Agency’s most important instruments to encourage the development of medicines for patients suffering from rare diseases.

The CHMP opinion on Translarna will now be sent to the European Commission for adoption of a decision on an EU-wide marketing authorisation.

Source: PharmaBiz

EMA recommends approval of Gazyvaro for chronic lymphocytic leukaemia

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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Gazyvaro (obinutuzumab) in combination with the cancer medicine chlorambucil for the treatment of adults with previously untreated chronic lymphocytic leukaemia.

Gazyvaro has an orphan designation. It is to be used in patients with additional medical conditions who cannot be treated with full dose fludarabine-based therapy.

Chronic lymphocytic leukaemia is a rare type of cancer which affects certain white blood cells called B-lymphocytes. It is a long-term debilitating and life-threatening disease as patients can develop severe infections. Chronic lymphocytic leukaemia accounts for approximately 30 per cent of adult leukaemias. In the European Union (EU), more than 62,000 people were diagnosed with leukaemia in 2012 and over 41,000 people died from the disease.

Chronic lymphocytic leukaemia remains an incurable disease. Treatments currently available generally induce remission, however the disease returns in nearly all patients.

Gazyvaro is a monoclonal antibody that targets B-lymphocytes, thereby helping the body’s immune system to kill the cancer cells.

The main study on which Gazyvaro’s recommendation is based is a phase III trial including 781 previously untreated patients with chronic lymphocytic leukaemia and coexisting medical conditions. The study showed that patients treated with Gazyvaro in combination with chlorambucil lived significantly longer without their disease getting worse compared to patients treated with chlorambucil alone (26.7 months versus 11.1 months) or rituximab plus chlorambucil (26.7 months versus 15.2 months). In addition, the risk of disease progression or death was reduced by 86 per cent when Gazyvaro was given with chlorambucil.

The safety profile of Gazyvaro was in accordance with what would be expected for a monoclonal antibody in this class. Infusion-related reactions, neutropenia and infections were among the most common adverse events reported. Some rare but serious adverse events were reported; however, the toxicity profile of Gazyvaro was considered acceptable in view of its benefits.

The applicant for Gazyvaro, Roche, received scientific advice from the CHMP during the development of the medicine. The advice pertained to quality, non-clinical and clinical aspects of the dossier.

The CHMP opinion on Gazyvaro will now be sent to the European Commission for adoption of a decision on an EU-wide marketing authorisation

Source: PharmaBiz

Finox Biotech’s bemfola gets European marketing authorisation for infertility treatment

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The European Commission has granted Marketing Authorisation (MA) for Finox Biotech’s bemfola (follitropin alfa solution for injection in pre-filled pens), a recombinant follicle stimulating hormone used for the treatment of infertility. This marketing authorisation follows a positive opinion by the European Medicines Agency, and allows for the marketing of bemfola in all of the 31 countries of the European Union (EU) and European Economic Area (EEA).

To date, nearly 400 patients have received at least one dose of bemfola in phase I or III studies. The MA for bemfola was supported by data from a large phase III study, in which bemfola  therapy was found to be similar to the currently available treatment – GONAL-f , based on the numbers of oocytes retrieved after completing FSH therapy. In this phase III study, similar efficacy and safety profiles were observed between the two study arms and similar numbers of live babies were born to patients who became pregnant following completion of therapy.

Gavin Jelic-Masterton, chief executive officer of Finox Biotech commented, “the marketing authorisation of bemfola  is an important step forward in the management of infertility in Europe, enabling many more patients the opportunity to obtain the treatment they need. We are confident that IVF Patients and Doctors across Europe will benefit from Finox Biotech’s commitment to quality, cost effectiveness and easy-to-use fertility medicines. bemfola  will be a great success for our company”.

Dr. h.c. Willy Michel, president of the board of Finox Biotech added, “This is the culmination of many years commitment to bringing a Swiss Quality r-FSH to the market in Europe and I believe that with the cost effectiveness of the product and sour state-of-the-art delivery system bemfola  will be very popular with physicians and patients. This also gives us the positive impetus to our ongoing development and registration efforts for the USA and Rest of World”

Bemfola was produced using recombinant DNA technology. Both bemfola and the reference product GONAL-f  are formulations of the naturally occurring hormone FSH, which plays a key role in human reproduction. bemfola is the result of a targeted drug development process aimed to replicate as closely as possible the reference product. The brief to the development engineers when designing the bemfola  injector device was to produce a Pen that absolutely minimised the number of steps a patient needs to take when preparing the injection and to ensure that the patient and physician had maximum control and the least chance of a patient error. The result, the bemfola  Pen, is therefore a simple, single-use, once-a-day disposable device, which allows the patient to self-inject.

Finox Biotech has agreed with the US FDA to conduct a pivotal phase III study (FIN3002) for registration of bemfola  (AFOLIA) in the USA. A US IND has been opened and the FIN3002 study is now in progress.

Finox Biotech  was founded in 2007 with a vision to become a leading company in the field of fertility therapies, by combining high quality Swiss medicines with innovative, award-winning delivery devices.

Source: PharmaBiz

GSK’s once-weekly diabetes treatment, Eperzan receives European marketing authorisation

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The European Commission has granted marketing authorisation for GlaxoSmithKline’s once-weekly diabetes treatment, Eperzan (albiglutide).
Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control as: Monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance; Add-on combination therapy, in combination with other glucose-lowering medicinal products, including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Vlad Hogenhuis, senior vice-president and head, GSK Global Cardiovascular, Metabolic and Neurosciences (CVM&NS) Franchise, said, “Diabetes treatment can be challenging for healthcare professionals and patients, often involving complex daily regimens, with almost 50 per cent of patients failing to meet their blood glucose targets. The authorisation of albiglutide means that healthcare professionals and patients will have access to a new once-weekly treatment option that has shown effective blood glucose lowering with durable control and is generally well tolerated.”

Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen and supplied with a short (5mm) thin-wall needle.  GLP-1 is an important incretin hormone that helps normalise blood glucose levels but, in people with type 2 diabetes, its production is reduced or absent. The EMA authorisation of albiglutide is based on the results of the comprehensive Harmony programme, comprising eight phase III studies.

The Harmony programme involved over 5,000 patients and evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, in patients at different stages of the disease, as well as those with renal impairment.   While many diabetes registration trials are just six months in duration, five of the Harmony trials included patient follow-up for up to three years.

GSK expects to launch albiglutide in several countries in Europe in Q3-4 2014 with additional launches to follow thereafter.

Albiglutide is currently undergoing review by other authorities, including the US Food and Drug Administration (FDA) and the US Prescription Drug User Fee Act (PDUFA) target date is 15 April 2014.

Eperzan is a trademark of the GlaxoSmithKline group of companies.

Source: PharmaBiz