GENEVA, Switzerland I June 6, 2016 I Novimmune, a Swiss biotech company focused on the discovery and development of antibody-based drugs, today announced that its lead program, NI-0501, has been declared eligible for PRIME (PRIority MEdicine) by the European Medicines Agency (EMA) for the treatment of primary Hemophagocytic Lymphohistiocytosis (HLH). The compound is currently in phase 2/3 of clinical development to treat HLH, a life-threatening disease of severe hyperinflammation which mainly occurs in children.
The PRIME scheme has been initiated by EMA to enhance support for the development of medicines that target an unmet medical need, helping patients to benefit as early as possible from therapies that may significantly improve their health condition or quality of life. Of the first wave of 18 medicines to apply for PRIME eligibility, NI-0501 is one of only 4 that were successful.
On 11th March 2016, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to NI-0501 for the treatment of patients with primary HLH with refractory disease, or with recurrent or progressive disease during conventional therapy.
Novimmune Chairman and Chief Executive Officer Eduard Holdener said: “Medicines agencies in both the US and the EU have now granted special status to NI-0501. This brings our lead program a big step closer to treating young patients who are suffering from a severe and often life threatening disease. We remain committed to developing novel medicines to provide improved treatment options for patients suffering from rare and devastating diseases such as HLH, autoimmune and inflammatory diseases or cancer.”
About Novimmune
Novimmune SA is a privately held, Swiss biopharmaceutical company focused on the discovery and development of antibody-based drugs for the targeted treatment of inflammatory diseases, immune-related disorders, and cancer. The company is headquartered in Geneva and currently employs 122 people. More information is available on the company website at www.novimmune.com.
SOURCE: Novimmune
Post Views: 77
GENEVA, Switzerland I June 6, 2016 I Novimmune, a Swiss biotech company focused on the discovery and development of antibody-based drugs, today announced that its lead program, NI-0501, has been declared eligible for PRIME (PRIority MEdicine) by the European Medicines Agency (EMA) for the treatment of primary Hemophagocytic Lymphohistiocytosis (HLH). The compound is currently in phase 2/3 of clinical development to treat HLH, a life-threatening disease of severe hyperinflammation which mainly occurs in children.
The PRIME scheme has been initiated by EMA to enhance support for the development of medicines that target an unmet medical need, helping patients to benefit as early as possible from therapies that may significantly improve their health condition or quality of life. Of the first wave of 18 medicines to apply for PRIME eligibility, NI-0501 is one of only 4 that were successful.
On 11th March 2016, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to NI-0501 for the treatment of patients with primary HLH with refractory disease, or with recurrent or progressive disease during conventional therapy.
Novimmune Chairman and Chief Executive Officer Eduard Holdener said: “Medicines agencies in both the US and the EU have now granted special status to NI-0501. This brings our lead program a big step closer to treating young patients who are suffering from a severe and often life threatening disease. We remain committed to developing novel medicines to provide improved treatment options for patients suffering from rare and devastating diseases such as HLH, autoimmune and inflammatory diseases or cancer.”
About Novimmune
Novimmune SA is a privately held, Swiss biopharmaceutical company focused on the discovery and development of antibody-based drugs for the targeted treatment of inflammatory diseases, immune-related disorders, and cancer. The company is headquartered in Geneva and currently employs 122 people. More information is available on the company website at www.novimmune.com.
SOURCE: Novimmune
Post Views: 77
