Drug giant GlaxoSmithKline (NYSE: GSK) received two doses of good news this week. An FDA committee on Thursday recommended its drug be approved for use in adults. Plus a new study says a cervical cancer vaccine appears effective with one dose.
Asthma drug update
The FDA panel backed the drug mepolizumab for treatment of sever asthma in patients 18 and older.
However, it did not endorse the drug for patients ages 12-17.
Patrick Vallance, president of Pharmaceuticals R&D for GSK, hailed the vote.
“Our clinical development program has demonstrated the potential of mepolizumab as a targeted treatment for difficult to treat adults with severe asthma, many of whom have been struggling to live with their condition for many years. These are patients who currently have very few treatment options and our belief in this medicine as a new treatment option has today been reinforced by the Advisory Committee’s decision. GSK will continue to work closely with the FDA to complete the review of the BLA for mepolizumab.”
The FDA is not obligated to follow the committee’s recommendations.
GSK would market the drug under the name Nucala, and it would be the first new “biologic treatment” for severe asthma in a decade, according to Reuters.
Asthma affects more than 22 million people in the U.S. alone with severe asthma afflicting between 5-10 percent of those, GSK says.
Cervical cancer vaccine study
Protecting girls from cervical cancer might be possible with just one dose of the HPV vaccine rather than the three now recommended, a new analysis suggests.
The authors of the study acknowledged it isn’t convincing enough to change vaccination strategies immediately. But if their results are confirmed, requiring just one dose of the vaccine could have a big impact on how many girls around the world get immunized.
Cervical cancer is the fourth-most common cause of cancer death in women worldwide and is estimated to kill more than 260,000 every year.
Researchers from the U.S. National Cancer Institute and elsewhere looked at data from previous trials covering more than 24,000 young women to see how much protection they got from one, two or three doses of the HPV vaccine, Cervarix. They estimated vaccine effectiveness after about four years to be between 77 percent and 86 percent for all the young women, regardless of how many shots they received.
If fewer doses could be used, “the potential is huge to prevent the deaths of millions of women,” said Julia Brotherton, medical director of the National HPV Vaccination Program Register in Australia.
The study was paid for by the U.S. National Cancer Institute and others including the vaccine’s maker, GlaxoSmithKline PLC. It was published online Wednesday in the journal Lancet Oncology.
