Originally Published June 15, 2015
This month’s column discusses Merck’s New Drug
Application (NDA) application to the Food and Drug Administration
(FDA), BMS’s Breakthrough Designation, a pharmaceutical collaboration,
and good news for patients who need help with co-payments for HCV
medications.
Merck
On May 28, 2015, Merck submitted a NDA to the FDA
for their combination of one pill (grazoprevir/elbasvir) taken
once-a-day to treat HCV genotypes 1, 4 and 6. Merck’s combination was
granted Breakthrough Therapy designation status for the combination by
the FDA for people with genotype 1 with end state kidney disease on
hemodialysis (to filter the kidneys) and for patients with genotype 4.
Breakthrough Therapy is given to a drug(s) to treat a serious or
life-threatening disease or condition when a drug may demonstrate a
substantial improvement over existing therapies. There were many
reports on Merck’s HCV medications from EASL 2015 that resulted in cure
rates up to 95-99% in people with genotype 1; 100% in genotype 4 and
80% in genotype 6.
Merck states that they will be
notified within 60 days if the FDA will accept their application for
review. Furthermore, Merck is expected to file additional licenses in
the European Union and other markets by the end of 2015. This will be
good news for paients—we may just have another choice of medications in
the near future.
BMS
Bristol-Myers-Squibb announced that they have been
granted Breakthrough Therapy Designation by the FDA for the combination
of daclatasvir and sofosbuvir. The cure rates of Daclatasvir,
sofosbuvir and ribavirin performed well in liver transplant patients
and in those who had advanced cirrhosis. I reported on a study from
EASL 2015 that in this population there was a cure rate of 76% to
100%.
Achillion and J&J Deal
It was announced in May that Johnson and Johnson
would collaborate with Achillion. The deal would mean that J & J
would invest in and help develop Achillion’s HCV 3 drug pipeline. The
three drugs are all in early development and could work on all HCV
genotypes, i.e., be pan-genotypic. J & J hopes to co-develop their
drug pipeline with Achillion and achieve an effective 6-week HCV
treatment cure.
Co-Pay Assistance
The current medications to treat hepatitis C can
have high co-payments. Presented here is another co-pay assistant
program for patients—HealthWell Foundation’s New Fund. For more
information visit their website at http://healthwellfoundation.org/ or contact: Ginny Dunn 240-632-5309, email Ginny.Dunn@HealthWellFoundation.org
http://hcvadvocate.org/news/newsLetter/2015/advocate0615_mid.html#4
Labels: HCV Drug update