Both Simeprevir and Sofusbuvir have been approved unanimously by FDA panel.
Excerpt from AP report on simeprevir (full link: ow.ly/qarKM from AGA twitter feed):
All 19 members of the Food and Drug Administration’s panel of virus experts voted in favor of approving J&J’s simeprevir, a daily pill designed to eliminate the most common form of hepatitis C. The FDA is not required to follow the group’s recommendations, though it often does. A decision on the drug is expected next month.
Roughly 3.2 million people in the U.S. have hepatitis C, a blood-borne disease that causes liver damage and is blamed for 15,000 deaths a year…
New Brunswick, N.J.-based J&J is seeking approval to combine its pill with the long-established drug cocktail used to treat the most common form of the virus.
Despite the unanimous vote Thursday, the panel’s endorsement came with a number of conditions.
The panelists stressed that the drug is less effective in patients with a common genetic mutation called Q80K, and that people with the abnormality should be screened out so they can receive other drugs. The group also said the drug’s label should warn patients and doctors that sunburn is a common side effect. Finally, panelists said that the FDA should require J&J to conduct additional studies of the drug’s effectiveness in minorities, especially African-Americans who are disproportionately infected…
The FDA meeting comes as federal health officials urge all baby boomers to get tested for the virus…
J&J’s simeprevir appears to be slightly more effective than the standard of care, curing 80 percent of patients who had not previously been treated for the disease, according to studies submitted to the FDA. More significantly, the drug helped most patients cut the amount of time they had to take the traditional drug cocktail, with its unpleasant side effects, to six months rather than one year. Additionally, panelists said the drug’s once-a-day dosage should be far more manageable for patients than the current drugs from Merck and Vertex, which require taking 12 pills or six pills a day, respectively.
And for Sofusbuvir from Reuters (FDA panel backs Gilead hepatitis C drug sofosbuvir)
The FDA advisory panel voted 15 to 0 in favor of approval of the drug in patients with two variants of the liver-damaging disease – genotype 2 and genotype 3 – in combination with an existing treatment, ribavirin.
If approved, it will be the first all-oral treatment for genotypes 2 and 3, obviating the need for the injectable drug interferon, which can cause debilitating side effects. Panelists called the vote “historic” and a “game-changer.”
“Our patients have been waiting for this for a long time,” said Dr. Curt Hagedorn, chief of medicine service at the Central Arkansas Veterans Healthcare Service.
The panel also voted unanimously to approve the drug in patients with genotype 1 and genotype 4 variants in combination with ribavirin and interferon in patients who have not received prior therapy.
Related blog posts:
- Emerging Targets for Hepatitis C -Part 1 | gutsandgrowth
- Emerging Targets for Hepatitis C -Part 2 | gutsandgrowth
- Pediatric HCV Guidelines | gutsandgrowth
- The cost of progress in treating Hepatitis C | gutsandgrowth
- HCV now more deadly than HIV | gutsandgrowth
- Vaniprevir for HCV | gutsandgrowth
- Missing “C” | gutsandgrowth
- More HCV options -phase 3 for Sofosbuvir | gutsandgrowth
- Curing Hepatitis C without interferon | gutsandgrowth