Prosensa muscle disease drugs are eligible for FDA accelerated review

Source: Ding Xiangyuan 2014-06-05 prosensa holding NV said that the company's latest drug for the treatment of muscle diseases was qualified by the FDA for rapid review The Dutch company said Thursday it plans to conduct more than two more experiments and submit them to the US for approval this year Prosensa said it would also submit European approvals in the near future Similar to the drug eteplirsen of Sarepta therapeutics, prosensa's drug for DMD is likely to be approved in the United States as early as 2015 Kerpel, an analyst at KBC securities in Brussels, said the drug is expected to occupy about half of the market share By the end of 2020, kerpel expects to generate a billion euros (US $1.36 billion) of global sales at the peak of the drug, which will cost about 200000 euros per patient per year Kerpel also said that prosensa's new drug has a patent advantage, and its sales in Europe are likely to be much higher than Sarepta's Drisapersen is similar to eteplirsen in that it increases the level of an anti atrophic protein, a deficiency of which can lead to pseudohypertrophic dystrophy In recent months, DMD drugs have received signals from regulators to encourage development The U.S Food and Drug Administration said it would provide a green channel for the approval of eteplirsen of Sarepta in April, and last month European regulators proposed conditional approval of transplana of PTC therapeutics In January, prosensa said that although drisapersen failed in later trials, there are data showing that the use of the drug can slow the disease, and the company will continue to seek the development of drisapersen Earlier this month, GlaxoSmithKline, a partner, returned the drug's rights to prosensa, while terminating a cooperative research and development agreement signed in 2009 Generally, the FDA will grant drugs for serious diseases without treatment plan based on some early clinical trial data to accelerate approval Of course, the company still needs to conduct larger scale experiments to strengthen the verification of its preliminary research results DMD is a degenerative disease that interferes with muscle movement One in 3600 new born boys gets sick, usually very seriously by the age of 30 Source address: http://