The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Merck & Co., Inc. (NYSE:MRK)’s Novel HIF-2α Inhibitor MK-6482. The product is a novel investigational candidate and one of Merck’s oncology products will be used in the treatment of “patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required.”
Offering innovative treatments to patients
In a statement by Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories said the company’s main agenda is to develop innovative treatments that meet all patients’ needs.
The FDA Breakthrough Therapy designation is granted to pharmaceutical companies to speed up the development and review of medicines that have been proposed for treatment of serious or life-threatening conditions. The designation is offered to drugs that have shown preliminary clinical evidence indicating that the medicine has the potential therapy on at least one clinically significant endpoint. On the other hand, the FDA’s orphan drug designation is given to drugs intended to treat, prevent, and diagnose a rare disease that affects less than 200,000 people in the U.S.
The company says its main agenda is to translate breakthrough science into innovative oncology treatments that can be used by cancer patients around the world. In addition, the company says it is exploring the potential for immuno-oncology. Merck is also strengthening its portfolio through strategic acquisitions a well as emphasis on the development of several promising oncology candidates.
Merck revises its FY profit guidance range
Last week Merck was optimistic about its worst-case scenario for full-year earnings as it started receiving patients that previously been in lockdown. The company projected its core earnings before special items in 2020 to be between 4.45 billion euros and 4.85 billion euros. This is an increase from an earlier projection of 4.35 billion.
The company said that the projections are based on the assumption that there would be no more lockdowns as a result of a second wave of infections. Another lockdown would have negative consequences for economic recovery.