New guidelines on Parkinson’s and antibacterials

by Gary Finnegan – Emerging uses of EMA Approved Drugs –

The European Medicines Agency has updated its guidelines for pharmaceutical companies developing medicines for Parkinson’s disease.

The revised guidance covers how companies should design and carry out studies of medicines that aim to improve the disease’s symptoms in patients and to modify the progress of the disease itself. The guideline was last published in 2008.

The update brings the guideline in line with recent scientific and medical developments in Parkinson’s disease. It includes new information on the definition of newly diagnosed patients and updates to the criteria for including patients in clinical trials and statistical analyses.

A number of medicines to treat the disease’s symptoms are authorised, but there are currently no authorised medicines that have been shown to stop its progression.

Meanwhile, the Agency has also released additional guidance as part of its public consultation on the development of antibacterials. The updated version provides additional guidance on the requirements for clinical studies related to specific indications and on clinical development programmes for new antibacterial agents targeted against rare or multidrug-resistant pathogens.

The publication of the addendum responds to requests for more detailed guidance on issues such as patient selection criteria and primary endpoints, including efficacy variables and the timing of the assessment of outcomes, made by the pharmaceutical industry and academia.

As part of the consultation process, the Agency will invite experts in the field for a second workshop on 25 and 26 October 2012 to discuss relevant aspects on the development of new antibacterials that have been addressed in the draft addendum. The workshop will focus on new development pathways for antibacterials targeting multidrug-resistant pathogens.

The comments received during the consultation period and the outcome of the workshop, together with experience gained with novel agents, will allow the refinement of the current text and the release of a consolidated version during 2013, the Agency said.

CHMP approves new medicines

The influential EMA Committee for Medicinal Products for Human Huse (CHMP) has given a positive assessment of several new medicines which are likely to be formally approved by the European Commission.

Newly-authorised products include Revestive (teduglutide) for the treatment of adult patients with short bowel syndrome. The product, by Nycomed Danmark, is the first therapy of its kind and can be used by “patients who are stable following a period of intestinal adaptation after surgery”.

Also approved was a series of new maintenance bronchodilator treatments from Novartis Europharm. The products – Enurev Breezhaler, Seebri Breezhaler and Tovanor Breezhaler – contain glycopyrronium bromide which can be used in adult patients with chronic obstructive pulmonary disease.

Elelyso (taliglucerase alfa) from Pfizer Ltd. Has been authorised for the treatment of type 1 Gaucher disease.

AstraZeneca AB received the green light for Zinforo (ceftraloline fosamil), indicated in adults for the treatment of complicated skin and soft tissue infections and community-acquired pneumonia.