Like every other prominent company in the healthcare business, Merck & Co., Inc. (NYSE:MRK) is chasing behind development of new drugs that can bring some needful changes in the world. But U.S. regulatory conditions don’t seem favorable to its approach. As per the reports, Merck recently announced that it didn’t have high hopes for approval of Sugammadex Injection.
Insights On The Matter:
The announcement came after U.S. regulators told Merck that they needed more time and inspections to check out sites in regard to the study of the drug that could reverse the deadly effects of anesthesia. Even though U.S. Food and Drug Administration has not yet given any official statement, but Merck expects a negative response from them. The final response will be delivered to the company by April 22, 2015. As per the reports, such complete response letters are meant to communicate that FDA is not willing to give the green signal to any company.
There was a request made by Merck in order to schedule a marketing meeting with the independent FDA medical advisory panel on March 18. But it has been canceled by FDA, which is a clear sign that it’s not interested in its proposal. The company added that despite this negative response from Merck, Merck would continue to work with FDA until this issue is cleared. Sugammadex is a well-known drug that improves the muscle relaxants after surgery has already been approved in more than 50 countries without any hassle, but conditions don’t look favorable in U.S., at least not now.
A renowned brokerage company Cowen & Co. has estimated that if the U.S. government approves Sugammadex now, then it can generate total annual sales of $550 million by year 2020. The entire country is in need of such drugs, and response of FDA is beyond anyone’s understanding. The management of Merck & Co., Inc. (NYSE:MRK) hopes that the situation will improve in the near future.