Vertex reports positive results for telaprevir against hep C
CAMBRIDGE, Mass. Vertex has released interim phase IIb clinical trial results for its hepatitis C drug telaprevir and it shows a potential breakthrough treatment for the disease.
The company said 49 of 60 chronic hepatitis C patients who took the experimental drug in combination with pegylated-interferon and ribavirin had a high rate of viral response at the four-week mark.
In the clinical trial, telaprevir, also known as VX-950, combined with pegylated interferon and ribavirin, is being given to chronic hepatitis C patients who failed to achieve sustained virological response on pegylated interferon plus ribavirin.
Amgen, Wyeth revise labeling for Enbrel
PHILADELPHIA and THOUSAND OAKS, Calif. Amgen and Wyeth Pharmaceuticals have informed health care professionals of revisions to prescribing information for their rheumatoid arthritis and psoriasis medication Enbrel.
The revisions include a boxed warning about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel.
Infections have included bacterial sepsis and tuberculosis. The adverse reactions section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel.
FDA approves Advair for wider use with COPD patients
WASHINGTON The Food and Drug Administration has approved GlaxoSmithKline’s asthma drug Advair to be used more widely to treat patients with chronic obstructive pulmonary disease, according to published reports. The drug had been approved to prevent wheezing and control other symptoms in COPD patients.
GSK’s approval comes the same day as rival AstraZeneca said it also was seeking FDA approval to sell its drug Symbicort for COPD.
COPD, an often-fatal lung condition with no cure, is a major market with more than 12 million Americans suffering from the disease, and another 12 million who are likely not diagnosed, according to the National Institutes of Health.
The FDA’s approval allows GSK to promote its product to COPD patients who experience flare-ups of the disease, which includes emphysema and chronic bronchitis.