New drug for hepatitis D! Eiger's first French-based metastase inhibitor lonafarnib was approved by the FDA for its breakthrough drug:

Eiger is a late-stage biopharmaceutical company dedicated to accelerating the development and commercialization of a range of targeted, pioneering therapies for the treatment of rare and ultra-rare diseases. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has granted Lomafarnib a breakthrough drug qualification (BTD) for the treatment of hepatitis D virus (HDV) infection. HDV is the most severe type of human virological hepatitis and there is currently no approved treatment. lonafarnib is a pioneering isoprene inhibitor developed for the treatment of HDV infection.
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases, and there is preliminary clinical evidence that the drug can substantially improve the condition compared to existing treatments. Access to BTD drugs can be developed with closer guidance, including from senior FDA officials, to ensure that new treatment options are available to patients in the shortest possible time.
awarded lorafarnib BTD by the FDA based on data from multiple Phase II clinical studies. These studies assessed the efficacy and safety of lonafarnib-based programmes for the treatment of HDV infections, and the data showed that among previously untreated HDV infections, lonafarnib-based programmes achieved a combined primary endpoint for reducing HDV RNA levels ≥2log10 and normalizing alanine amino transferase (ALT), reflecting improvements in liver condition and virological response.
David Apelian, Chief Operating Officer and Executive Medical Officer of Eiger, said, "There is an urgent medical need in HDV treatment, which is the most serious type of viral hepatitis. We look forward to working closely with the FDA to accelerate the development of lorafarnib treatment for HDV. We are currently conducting Phase III D-LIVR, the first ever globally registered HDV study, which promises to bring 2 different, lorafarnib-based treatments to the HDV patient population.
lonafarnib is a distinctive late-stage oral activity inhibitor targeting the faniki transferase, which is involved in the modification of proteins through a process called isoprene. HDV uses this host cell process in liver cells to complete a key step in its life cycle. Lonafarnib inhibits isoprene steps for HDV replication in liver cells, blocking the virus life cycle during the virus assembly phase. Lonafarnib has been treated in more than 120 cases of HDV infection at international academic centers and is currently in the midst of a critical PHASE III clinical study. In the United States and the European Union, lonafarnib has been granted the orphan drug qualification, and in the United States was granted fast-track qualification. Lonafarnib has not been approved for any of the allergies, and the drug was licensed from Mercadon.
is caused by HDV infection and is the most serious type of human viral hepatitis. Hepatitis D occurs only as a co-infection in individuals with the hepatitis B virus (HBV), causing liver disease more severe than hepatitis B and accelerating liver fibrosis, liver cancer and liver failure. Hepatitis D is a disease that seriously affects human health worldwide and can affect about 15 to 20 million people worldwide. Hepatitis D is endemic in different parts of the world. Globally, about 4.3%-5.7% of people with chronic hepatitis B virus are reported to have HDV infection. In some regions, including Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, the Middle East and South America, the prevalence of HDV among people infected with chronic HBV is even higher, with HDV prevalence reported to be as high as 60% in hives in Mongolia and Pakistan (biogu).