Lung Drugs News: October 2006 Archives

Drugmaker paying $37 million for off-label marketing


Drugmaker InterMune Inc. agreed Thursday to pay $37 million to settle charges it promoted a drug to treat a fatal lung disease even though it was approved for a different ailment and its own studies didn't show it was effective.

The drug Actimmune is approved by the Food and Drug Administration to treat an immune system disorder and a bone disease but was often prescribed off-label to treat a lung-scarring condition known as Idiopathic Pulmonary Fibrosis.

Federal authorities said the vast majority of Actimmune sales between August 2002 and January 2003 were for treating IPF, a disease afflicting 83,000 Americans in which there is no FDA-approved treatment.

Asthma approval bolsters biotech


Asthma approval bolsters biotechFORMER junior biotech Pharmaxis took its biggest step towards becoming a fully-fledged pharmaceutical company yesterday, winning a Swedish licence for its asthma drug Aridol.

Shares in Pharmaxis surged 4 per cent or 11c to $2.78 after the announcement, with analysts predicting it would earn 80 per cent gross margins on Aridol amid projected global revenue of $250 million.

Discovered, developed, manufactured and marketed over 12 years in Australia without offshore backing or collaboration with a big pharmaceutical company, the drug is claimed to allow accurate asthma diagnosis for the first time.

GSK Submits Supplemental Drug Application for Advair in COPD


RESEARCH TRIANGLE PARK, N.C., Oct. 11, 2006 /PRNewswire/ -- GlaxoSmithKline (GSK) announced today that it has submitted a supplemental new drug application to the FDA to expand labeling for Advair Diskus(R) (fluticasone propionate and salmeterol inhalation powder) based on results from TORCH, a three year study that showed a reduction in the risk of death and the rate of COPD exacerbations, and other supporting studies.

COPD, or chronic obstructive pulmonary disease, is a complex lung disease that results in a progressive decline in lung function that is ultimately debilitating and life-threatening. It is the 4th leading cause of death in the U.S.

Cisplatin and Vinorelbine Standard of Care in Lung Cancer


The combination of cisplatin with vinorelbine should be the standard of care for non–small-cell lung cancer (NSCLC) after complete resection, as there is now clear evidence that it provides major benefits, attendees at the 31st Congress of the European Society of Medical Oncology (ESMO) heard yesterday. The conclusions come from the latest meta-analysis of the Lung Adjuvant Cisplatin Evaluation (LACE), presented at the meeting by Jean-Yves Douillard, MD, from the Centre R Gauducheau in Nante-St. Herblain, France.