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Merck Presents 96-Week Doravirine HIV Data Three Months before PDUFA Date

on Fri Jul 27, 2018 4:57 am
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96-week data on doravirine, Merck’s HIV drug, was posted by the drugmaker recently. Merck expects it to outrun drugs like Bristol-Myers Squibb’s Sustiva in combination regimens and antiretroviral drugs from AbbVie and Johnson & Johnson in viral suppression.
Merck believes that the present drugs added to Gilead’s Truvada and ViiV Healthcare’s Epzicom possess certain inadequacies. Bristol-Myers’ Sustiva observed an elevated rate of specific side effects compared to non-nucleoside reverse transcriptase inhibitors (NNRTIs), and J&J’s Edurant combats excessive viral loads with difficulty. Boehringer Ingelheim’s Viramune and J&J’s Intelence also come with shortcomings.
Merck attempts to take advantage of this scenario by propagating doravarine. Last year, it presented the efficacy of the NNRTI to be at par with a combination of AbbVie’s Norvir and J&J’s Prezista at containing the HIV virus after 48 weeks, followed by a filing for FDA approval with a PDUFA dated October 23rd.
The 96-week update shows that doravirine exceeded Gilead or ViiV’s drugs in the rate of viral suppression in HIV patients showing a fall by 10 percentage points over the second 48 weeks of the trial. Moreover, it fared better than the Norvir-Prezista combination in the control division with the rate of viral suppression declining by 14 percentage points. The variance in viral suppression in the doravirine and the control group was equal to7.1%.
It did not ring any bells for safety hazards during the 96-weeks. Also, it does not lead to a rise in fasting serum blood lipids as seen with the Norvir-Prezista combination and showed a lesser rate of dropouts due to adverse events than the control section.
Merck presents the update three months before the verdict of the FDA on the approval of doravirine as a single drug and in combination with lamivudine and tenofovir.
The post Merck Presents 96-Week Doravirine HIV Data Three Months before PDUFA Date appeared first on Drugdu.com
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