Ligand (LGND), Glaxo (GSK) Receive FDA Approval for PROMACTA in HCV Patients
Get Alerts LGND Hot Sheet
Join SI Premium – FREE
Ligand Pharmaceuticals (Nasdaq: LGND) partner GlaxoSmithKline (NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has approved PROMACTA for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. PROMACTA is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts. PROMACTA in combination with interferon-based therapy has been shown to improve a patient’s chance of achieving a sustained virologic response (SVR) or viral cure.
There are limitations to the use of PROMACTA in patients suffering from chronic hepatitis C-associated thrombocytopenia. These include:
* PROMACTA should not be used in an attempt to normalize platelet counts;
* PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy; and
* Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.
There are limitations to the use of PROMACTA in patients suffering from chronic hepatitis C-associated thrombocytopenia. These include:
* PROMACTA should not be used in an attempt to normalize platelet counts;
* PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy; and
* Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Acrivon Therapeutics (ACRV) Reports Initial Positive Clinical Data for ACR-368 and Pipeline Program Progress Today at Corporate R&D Event
- Boeing (BA) Statement on U.S. Air Force Collaborative Combat Aircraft Announcement
- ADT Corp. (ADT) Appoints Jeffrey A. Likosar as Permanent CFO
Create E-mail Alert Related Categories
Corporate News, FDA, Trading HaltsSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!