The European Medicines Agency (“EMA”) recently granted Orphan Medicinal Product designation in the EU to MIV-818 used for the treatment of patients with hepatocellular carcinoma (“HCC”), the primary type of liver cancer. This designation was granted after thorough and careful medical research and guidance about the drug. Orphan Medicinal Product designation gives specific regulatory and financial bonuses to firms to help in developing and marketing therapies that treat chronically debilitating conditions or life-threatening diseases. Studies show that five people in a population of 10,000 individuals are suffering from HCC, a fatal ailment in the European Union. The designation has been initiated to give access to several incentives, including potential for 10-year market exclusivity, the EU centralized authorization procedure, and protocol assistance.
About Hepatocellular Carcinoma (“HCC”)
HCC is ranked the fifth most common type of cancer globally, but it is a rare disease in the U.S. and Europe. HCC occurs mostly in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or C infection. Hepatocellular Carcinoma is more common in people who have an accumulation of fat in the liver and those who drink large amounts of alcohol. Though the therapies for this condition do exist, the treatment benefits for both advanced and intermediate forms of the disease are meagre while the mortality rates remain very high. HCC is an extreme ailment with several cancer cell types and does not have tumor-specific mutations. This attribute has contributed to the lack of success of molecularly targeted agents in HCC interventions. The overall insufficient benefit, together with poor prognosis for patients with advanced and immediate HCC, has led to a significant unfulfilled medical need.
It is a pro-drug that has been carefully designed to treat liver cancer cells while minimizing the side effects selectively. MIV-818 has all the potentials to become the eminent liver-targeted, orally administered medicine for patients with HCC. It is also efficient in treating other forms of liver cancer since most cancer drugs have reduced efficacy in oxygen-poor tissue, but MIV-818 works very well with such membranes.
If this drug performs well during the subsequent stages of its development, patients will finally have hope of a better quality of life and a fighting chance to beat HCC which is currently seen as a kind of death sentence due to the minimal effect that the current medicines have been having. Hope of having a real fighting to beat serious diseases is exactly what biomedical companies like DarioHealth Corp. (NASDAQ: DRIO) strive to do by engaging in cutting-edge R&D.
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