EMA grants ODD Status to Stempeutics for Allogeneic Stem Cell Drug

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image004Stempeutics Research, a group company of Manipal Education & Medical Group and a Joint Venture with Cipla Group, has received Orphan Drug Designation (ODD) from European Medicines Agency (EMA) for its drug Stempeucel. This drug is to be used for the treatment of Thromboangiitis Obliterans.

Mr BN Manohar, CEO of Stempeutics said, “Obtaining Orphan Designation for Stempeucel in the European Union (EU) is an important regulatory milestone for Stempeutics. The benefits include 10 years of market exclusivity from product launch in the EU, fee reductions, as well as access to the central authorization procedure. This orphan drug designation supports Stempeutics global development strategy for Stempeucel drug and the goal of providing improved therapies for patients with Thromboangiitis Obliterans”.

Stempeucel treatment is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularization.

Thromboangiitis obliterans or Buerger’s Disease is a rare and severe disease affecting the blood vessels of the legs. It is characterised by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, thus leading to severe pain and ulcers or necrosis, which finally may require amputation.

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