The FDA approved eierjian's new schizophrenia drug cariprazine

Source: Biovalley 2015-09-18 September 18, 2015, if there is anything that bothers the pharmaceutical developers most, there is no better thing than that the drug can't get the "favor" of relevant pharmaceutical management departments after passing the clinical stages I, II and III In fact, in the process of approval of many new drugs every year, many drugs are rejected by FDA for various reasons after spending a huge amount of R & D funds Although most biopharmaceutical companies will continue to supplement data, some drugs may lose the best time to seize the market due to the long delay in listing, which greatly reduces the value of new drugs Recently, pharmaceutical giants Elgin and Richter have been faced with this mixed situation The FDA recently announced the approval of cariprazine, a new antipsychotic drug jointly developed by the two companies The drug is mainly designed to treat schizophrenia and bipolar disorder In 2013, when cariprazine was first submitted to FDA for approval, management asked the company to provide more clinical research data to determine the optimal dosage of the drug For this reason, in the past two years, Elgin and Richter have carried out a third phase clinical study to prove that they can indeed reduce the incidence of schizophrenia Combined with the previous research data of 2700 schizophrenics and manic depression patients, Elgin and Richter finally captured FDA's "heart" Cariprazine will be listed under the name of vraylar But while the news is to be celebrated, it may be hard for Elgin and Richter to be happy Cariprazine was once expected to peak at as much as $2 billion However, with the ups and downs of the drug approval process, the enthusiasm of analysts and the market for the drug has been constantly reduced After the news of the listing, some analysts have reduced their annual sales peak to 200 million US dollars, a 10 times reduction However, the approval of cariprazine is still a happy thing Richter executives say there is still a lack of good enough therapies in the field of schizophrenia and other mental diseases, and the drug's launch can ease the urgent need of patients for such drugs The relationship between Erjian and the drug is tortuous Richter and forest laboratories reached a cooperation agreement on the research and development of the drug in 2004 In 2014, Actavis won the right to the drug after taking the lead of forest laboratories with a price of 25 billion US dollars The merger of Actavis and Elgin earlier this year finally enabled Elgin to take the drug into its pocket.