FDA approves GSK drug for hepatitis C patients with low platelet counts
LONDON — The Food and Drug Administration has approved a drug for a condition that can complicate treatment for hepatitis C.
GlaxoSmithKline said Monday that the FDA had approved Promacta (eltrombopag) for treating low blood-platelet counts, also known as thrombocytopenia, to allow patients with hepatitis C to undergo and maintain interferon-based therapy. The drug already had FDA approval to treat chronic immune thrombocytopenia.
"Some chronic hepatitis C patients suffer from low blood platelet counts," GSK Oncology president Paolo Paoletti said. "Commonly prescribed interferon-based therapies can worsen the problem of low blood-platelet counts. Today’s FDA approval of Promacta gives doctors a tool to address the low platelet challenge."
Dr. Reddy’s launches PAH drug
HYDERABAD, India — Dr. Reddy’s Labs has launched a generic drug for treating pulmonary arterial hypertension, the company said.
Dr. Reddy’s announced the launch of sildenafil tablets in the 20 mg strength in 90-count bottles. The drug is a generic version of Pfizer’s Revatio.
Revatio had sales of $338.67 million during the 12-month period ended in September, according to IMS Health.
Shire launches rare-disease research project
LEXINGTON, Mass. — Drug maker Shire has started a research program focused on rare diseases and their effects on patients and healthcare professionals, the company said Monday.
Shire announced the launch of the Shire Rare Disease Impact Report, which includes surveys of patients, caregivers, physicians, payers and others in the United States and United Kingdom, with results expected in the first half of 2013.
According to the Global Genes Project, about 7,000 types of rare diseases affect an estimated 350 million people worldwide and are often chronic, progressive, degenerative, life-threatening and disabling.
"Despite the progress that has been made over the past few decades in the rare disease space, there is still an urgent need to better understand this community and its needs," said Nicole Boice, founder and CEO of the Global Genes I R.A.R.E. Project and a member of the project’s advisory board. "I’m thrilled to be involved in the development of this Rare Disease Impact Report, as its findings will help elevate awareness for the rare disease community and guide future research and education for affected patients and their families."
Other members of the advisory board are Priya S. Kishnani, Duke University Medical Center division chief for medical genetics; Tomas Philipson, professor of public policy studies at the University of Chicago; Alastair Kent, director of the Genetic Alliance UK; Christian Hendriksz, clinical lead for adult inherited metabolic disorders at the United Kingdom’s Salford Royal NHS Foundation Trust; and Mike Drummond, professor of health economics at the University of York.
"At Shire, patients are at the heart of everything we do, and we continually strive to provide support for those touched by rare diseases," Shire HGT president Sylvie Gregoire said. "We hope the findings from this Rare Disease Impact Report will provide the rare disease community at large with new, unique insights on how best to address the holistic needs of the rare disease community and drive important conversations and innovation."
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