GlaxoSmithKline recently advised the public that the US FDA’s Vaccines and Related Biological Products Advisory Committee voted that Ceravix, the company’s cervical cancer vaccine, presented data that substantiates the efficacy and safety of the treatment.

With regards to the prevention of cervical pre-cancers and cervical cancer relevant to human papillomavirus (HPV) types 16 and 18, Ceravix proved to be both extremely impactful and satisfactory endured in girls and young women.  In addition, the committee conversed on data which presented Ceravix’s efficacy while in contact with other cancer-causing viruses.

GlaxoSmithKline’s Vice President and Director of North American Vaccine Development, Barbara Howe, MD exclaims that their recent favorable FDA recommendations marks and “important step in cancer prevention for the millions of girls and young women at risk for cervical cancer … if approved, Ceravix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in US women each year.”

The FDA will review the committee’s commendatory advice during its concluding evaluation of the Biologics License Application for the candidate vaccine.  If accepted, the FDA will finalize prescribing information.

General side effects displayed during clinical trials of the Ceravix vaccine were pain, swelling and redness, fatigue, headache, muscle ache and joint pain, gastrointestinal  symptoms and fever.  Major side effects were mainly similar between the groups who received Ceravix and the control groups.

March of 2009, marks the date when GSK presented their Phase III pivotal study concluding data, a trial study that was the biggest efficacy trial of a cervical cancer vaccine.  The data included information harvested from clinical trials hosted in more than 30 countries which utilized 30,000 Ceravix participants, revealing an ethnically and racially varied female population.  The study also covered a rigorous safety assessment  applicable to girls and young women between the ages of 10-25.

]]> http://dev.orderonlinedrugs.com/daily-health-and-medical-news/2009/09/10/ceravix-receives-advise/feed/ 1 http://dev.orderonlinedrugs.com/daily-health-and-medical-news/2009/08/17/saphris-sublingual-tabs-receives-fda-endorsement/ http://dev.orderonlinedrugs.com/daily-health-and-medical-news/2009/08/17/saphris-sublingual-tabs-receives-fda-endorsement/#comments Mon, 17 Aug 2009 20:38:51 +0000 admin http://www.orderonlinedrugs.com/drug-news/?p=221 The US FDA has approved Saphris sublingual tablets for the acute therapy of schizophrenic adults, as well as the acute therapy of manic or mixed bipolar I disorder, with or without adult psychotic attributes.  Saphris is endorsed for first-line therapy, and is the first prescription drug to receive primary consent for both of these symptoms concurrently.

Shering-Plough, the research company behind Saphris are overly “pleased with the U.S. approval of Saphris, which represents an important new  choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder in patients starting treatment and those who have discontinued previous treatment.”  Schering – Plough Research Institute, executive vice president and president Thomas P. Koestler, PhD went on to express their excitement with Saphris’ addition to their “product portfolio, and represents the first U.S. approval resulting from Organon/Schering – Plough combination.”

The FDA endorses Saphris, issues from a New Drug Application that contains efficacy data from their clinical study program which encompassed roughly 3,000 schizophrenic and mania trial patients.  Saphris’ new drug application was also reinforced by safety data issued from 4,500 people, some of which were treated for over two years.  The FDA’s endorsement stems from acute schizophrenia trials, where Saphris showed noteworthy statistical efficacy when compared with placebo and acute bipolar l disorder studies, in which, Saphris proved statistically, an immense lowering of bipolar symptoms versus that of the placebo trials.

The study has finished after 52 weeks of lupus patients being treated by Benlysta, and showed significant patient improvement overall, without any crucial flare-ups in one or more isolated organs when compared to placebo patients.  In addition, Benlysta patients were able to minimize their steroid intake.

This is the largest study to have been conducted and completed for lupus and the first Phase III (late stage) trial of a new biological immune therapy.   Benlysta is the first lupus treatment option to emerge in the last 50 years.  Benlysta will undergo another study, which will focus on a longer-term Phase III clinical study.  The data from both studies will be evaluated by the US FDA, pending approval.