Bristol-Myers Squibb Co (NYSE:BMY)’s Hepatitis C drug has been put on hold by FDA regulators.
According to a recent press release, Bristol-Myers’ Hepatitis C drug had been declined approval by the U.S. authorities. The news concerns daclatasvir, which is essentially used in the combination therapy along with asunaprevir. The latter is an antiviral drug.
Bristol-Myers Squibb Co (NYSE:BMY) announced yesterday that it had submitted data from its findings on the combination treatment to the Food and Drug Administration earlier. The filing was to get the approval of the use of daclatasvir with asunaprevir. However, the American drug manufacturer had withdrawn its application in October. This is because the FDA was asking for more data to validate the effects of the combination of daclatasvir and asunaprevir in the treatment of Hepatitis C. The company is now in talks with the FDA in the matter.
Daclatasvir belongs to the drug category of NS5A inhibitors and is currently popular among researchers from across the world. In addition to studying its efficacy in the treatment of Hepatitis C, scientists are also evaluating the drug’s effect on other diseases. Some major studies currently employing the drug include those on HIV patients and those who have undergone a liver transplant.
Apart from the collection of additional data, Bristol-Myers Squibb Co (NYSE:BMY) is also seeking to conduct further experiments to collect the needed data. The matter is so significant because as of now, Hepatitis C is the most focused research area in the field. Hence, Bristol-Myers is also seen to shift focus from its popular drug treatments for gene-related diseases, viral diseases, cardiac diseases and cancer.
In this context, Bristol-Myers Squibb Co (NYSE:BMY)’s RnD head, Francis Cuss, commented that the studies on the treatment for Hepatitis C still are short of achieving significant milestones. He further added that the company is determined to prove the efficacy of daclatasvir in the Hepatitis C combinational drug therapy to the FDA.