NECT (Nifurtimox-Eflornithine Combination Therapy), a new treatment option for sleeping sickness, a fatal disease that threatens 60 million people across sub-Saharan Africa, has been added to the Essential Medicines List (EML) of the World Health Organization (WHO). The inclusion is based on an application submitted by the non-profit Drugs for Neglected Diseases initiative (DNDi), supported by the international medical humanitarian organization Doctors Without Borders/Medecins Sans Frontières (MSF), and Epicentre, MSF’s epidemiological research center.

According to the WHO, NECT can now be used in patients and will provide an opportunity to improve the management of sleeping sickness cases. WHO has already made preparations for the arrival of this improved therapeutic opportunity and will work to ensure that patients have access to NECT by providing appropriate training and by supplying the drugs and necessary equipment to disease-endemic countries.

NECT, a co-administration schedule of oral nifurtimox and intravenous eflornithine, is made available through donations to WHO by Sanofi-Aventis (eflornithine) and Bayer (nifurtimox). A pivotal, five-year long Phase III study comparing NECT with eflornithine used alone was recently completed by a partnership including Epicentre, MSF, DNDi, the Swiss Tropical Institute, and the national sleeping sickness control programs of the Republic of the Congo and the Democratic Republic of the Congo.

“This study was built on previous Epicentre and MSF studies that identified this particular drug combination as a promising therapy,” said Emmanuel Baron, director of Epicentre. “It has provided some of the strongest evidence in sleeping sickness research to date, and has demonstrated NECT to be a better treatment option for advanced-stage sleeping sickness, as compared with the two current treatments which are either toxic or too complicated to use.”

“NECT is critical in our efforts to address the needs of neglected patients suffering from a fatal disease,” said Christophe Fournier, president of MSF’s international council. “This improved treatment needs to be rolled out urgently to replace the current, most commonly used therapy that kills one in every 20 patients.”

“We at DNDi welcome this decision and the rallying by the sleeping sickness community in support of this application as it underscores the practical improvement and impact NECT can make in the field today,” said Bernard Pecoul, executive director of DNDi. “No new drugs for stage two sleeping sickness are expected in the next five years, so there is an urgent need to develop new treatments based on currently available drugs, especially through combinations. However, even with the importance of this development, we have made but one step on the path to ultimately meeting patient needs.”

Click here to access WHO information about NECT inclusion onto the Essential Medicines List

Source
Doctors Without Borders/Medecins Sans Frontières (MSF)

The European Medicines Agency has been formally notified by Sepracor Pharmaceuticals Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Lunivia (eszopiclone), 2 and 3 mg tablets.

Lunivia was expected to be used for the treatment of insomnia, including difficulty falling asleep, nocturnal awakening or early awakening in adults, usually for short-term duration.

The application for the marketing authorisation for Lunivia was submitted to the Agency on 23 July 2007. In October 2008, Lunivia received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending that the medicine be granted a marketing authorisation. However, the CHMP recommended that the medicine should not be granted ‘new active substance’ status.

Following a re¬examination procedure at the request of the applicant, the CHMP confirmed its previous opinion in February 2009. At the time of withdrawal, the application was pending the adoption of a marketing authorisation decision by the European Commission.

In its official letter, the company stated that the withdrawal of the application was based on the CHMP’s recommendation that Lunivia should not be regarded as containing a new active substance, and that the commercial viability of launching the product in the European Union was compromised.

More information about Lunivia and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the Agency’s website after the next CHMP meeting of 26-29 May 2009.

Notes

1. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.

2. The press release from the October 2008 meeting can be found here.

3. The summary of the positive opinion from October 2008 can be found here.

EMEA

CardioNet, Inc. (NASDAQ:BEAT) announced the launch of SomNet ™, a new clinical indicator available in the Company’s existing Mobile Cardiac Outpatient Telemetry™ (MCOT™) system. Because many patients with cardiac disorders also suffer from common sleep disorders like sleep apnea, CardioNet believes that SomNet has the potential to identify patients with a high likelihood of such sleep disorders by measuring cyclic variation of heart rate (CVHR), a rhythm that is caused by repeated arousals from sleep due to such disorders. SomNet’s utility is based on data presented at the Heart Rhythm Society’s (HRS) 30th Annual Scientific Sessions in Boston.

“There is a high prevalence of sleep disorders like sleep apnea in the cardiovascular and arrhythmia population,” said Randy Thurman, CEO of CardioNet. “The data collected by SomNet is extremely valuable information that can be captured from our existing MCOT ECG signal. If clinically appropriate, physicians may choose to refer patients with CVHR patterns to sleep centers for further diagnostic testing, to determine if they have sleep apnea or another serious sleep disorder.”

In an 80-patient study presented today at HRS, Phyllis K. Stein, Ph.D., Research Associate Professor of Medicine at Washington University School of Medicine, found that automated identification of clinically relevant CVHR is feasible using CardioNet’s MCOT system. The study compared MCOT automatic analysis of CVHR patterns versus a human expert’s direct analysis of plots of HR patterns for measuring clear (large amplitude) CVHR. Findings showed similar specificity and positive predictive value measures between MCOT and human expert analysis, with slightly lower sensitivity measures for the automated analysis.

“Although slightly less sensitive than more labor intensive human overreading, the MCOT system and SomNet may provide a platform for efficiently identifying patients with severe sleep disorders, like sleep apnea, in a large population,” said Dr. Stein.

Source
CardioNet, Inc.