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Good news for all - plans for 7977
There is great news for here everybody. By everybody, I mean all genotypes regardless of degree of liver damage or prior null response to interferon.
http://www.gilead.com/swf/fireside_chat.mp3
For those that don’t want to listen to the whole audio presentation, I have listed up the points that caught my attention most of all. There is much more information in the presentation.
-- Gilead expects filing for FDA approval of GS 7977 in late 2013 with approval to quickly follow in early 2014.
-- FDA has made regulatory pathways much easier to negotiate. The combination of dosing periods lasting only 12 weeks and FDA standards for SVR reduced to 12 weeks post treatment is ensuring quicker approval times. A 2013 release date for GS 7977 is a reasonable estimate of time rather than a "best" case scenario.
-- GS 7977 has displayed no significant side effects or adverse drug interactions to date. It is very safe.
-- Gilead is preparing to run 7977 trials for harder to treat Hepatitis C conditions without waiting for data from the other trials. These will include all the varieties of pre transplant conditions in Phase III. The goal is to release GS 7977 to be used for treating all genotypes at all stages of HCV disease progression from the start.
-- Gilead has a drug GS5885 which is effective for genotypes 1 and 4 which is a candidate for testing with GS 7977.
-- Trials involving GS 7977 will no longer necessarily involve an interferon arm but rather a placebo arm which turns around to a treatment arm after a period of time.
-- GS will try to pair some of the other GS drugs with GS 7977 or ribavirin with it.
-- Combining GS 7977 with BMS was not ruled out and studies continue.
-- Treatments involving Interferon will become unnecessary. In the near future Hep C will be treated with a two-drug combo lasting 12 weeks. Initially this may include Ribavirin but that will be replaced quickly by a number of less toxic alternatives. The treatment will be safe and simple so that many more people can be treated by a wider range of medical professionals.
Enjoy the new future. It is much much brighter!
http://www.gilead.com/swf/fireside_chat.mp3
For those that don’t want to listen to the whole audio presentation, I have listed up the points that caught my attention most of all. There is much more information in the presentation.
-- Gilead expects filing for FDA approval of GS 7977 in late 2013 with approval to quickly follow in early 2014.
-- FDA has made regulatory pathways much easier to negotiate. The combination of dosing periods lasting only 12 weeks and FDA standards for SVR reduced to 12 weeks post treatment is ensuring quicker approval times. A 2013 release date for GS 7977 is a reasonable estimate of time rather than a "best" case scenario.
-- GS 7977 has displayed no significant side effects or adverse drug interactions to date. It is very safe.
-- Gilead is preparing to run 7977 trials for harder to treat Hepatitis C conditions without waiting for data from the other trials. These will include all the varieties of pre transplant conditions in Phase III. The goal is to release GS 7977 to be used for treating all genotypes at all stages of HCV disease progression from the start.
-- Gilead has a drug GS5885 which is effective for genotypes 1 and 4 which is a candidate for testing with GS 7977.
-- Trials involving GS 7977 will no longer necessarily involve an interferon arm but rather a placebo arm which turns around to a treatment arm after a period of time.
-- GS will try to pair some of the other GS drugs with GS 7977 or ribavirin with it.
-- Combining GS 7977 with BMS was not ruled out and studies continue.
-- Treatments involving Interferon will become unnecessary. In the near future Hep C will be treated with a two-drug combo lasting 12 weeks. Initially this may include Ribavirin but that will be replaced quickly by a number of less toxic alternatives. The treatment will be safe and simple so that many more people can be treated by a wider range of medical professionals.
Enjoy the new future. It is much much brighter!
Oops I made a typo in one spot there. Should be appllication for approval in late 2013 and actual release in 2014.
It certainly is wow, just wow and wow again.
It certainly is wow, just wow and wow again.
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