EU grants orphan drug status to Strekin’s STR001 for Sudden Sensorineural Hearing Loss

European Medicine Agency (EMA) has granted orohan drug designation to Sterkin AG, a clinical stage biopharmaceutical company’s development candidate STR001 for the treatment of patients with Sudden Sensorineural Hearing Loss.

FDA and EMA grants orphan drug designation to those products like drugs and therapies that treat rare diseases. The administration defines rare diseases as those affecting fewer than 200,000 people in United States. Orphan drug designation provides certain financial benefits such as incentives to the developing company. These benefits include market exclusivity for the marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.

“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.

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