The European Medicines Agency (EMA) has declared Swiss biopharmaceutical company Novimmune’s lead programme, NI-0501, as eligible for PRIority MEdicine (PRIME) for the treatment of primary Hemophagocytic Lymphohistiocytosis (HLH).
The HLH compound is currently in its Phase II / III of clinical development in order to treat patients affected with HLH.
HLH is a life-threatening disease of acute hyperinflammation primarily occuring in children.
Novimmune chairman and chief executive officer Eduard Holdener said: "Medicines agencies in both the US and the European Union (EU) have now granted special status to NI-0501.
"This brings our lead programme a significant 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."
EMA has initiated the PRIME scheme with an aim to increase its support for the development of medicines that are used to treat an unmet medical need.
This will help patients benefit as early as possible from several therapies that might result in significant improvement in their health condition or quality of life.
Of the first lot of 18 medicines that had applied for PRIME eligibility, only four medicines including NI-0501 turned out to be successful.
On 11 March this year, Novimmune’s NI-0501 was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of patients suffering from primary HLH with refractory disease, or with recurrent or progressive disease during conventional therapy.
Image: Micrograph of hemophagocytic syndrome. Photo: courtesy of Nephron.