Breakthrough therapy in Europe for Novimmune

Novimmune submits Marketing Authorisation Application in Europe for its lead drug emapalumab

Geneva and Basel, 22nd August, 2018 — Novimmune, a Swiss biotech company focused on the discovery and development of antibody-based drugs, today announced that it has successfully submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking marketing approval for its lead compound, emapalumab (NI-0501), for the treatment of patients with primary Hemophagocytic Lymphohistiocytosis (HLH).

Novimmune Chairman and Chief Executive Officer Eduard Holdener said: “This application  is a very important event for children suffering from HLH as it represents a big step towards emapalumab becoming available in the future in Europe.” 

Cristina de Min, Novimmune’s Chief Medical Officer, added, “We are delighted that the emapalumab research and development program has now advanced to the product registration phase also in Europe. We look forward to working with the EMA during the review process for the first targeted therapy for primary HLH.”

Novimmune filed a Biologics License Application (BLA) for emapalumab with the FDA earlier in the year and was granted Priority Review with a PDUFA (Prescription Drug User Fee Act) goal date for review completion of November 20, 2018.

On 11th March 2016 the FDA granted Breakthrough Therapy Designation to emapalumab . Three months later, the compound was declared eligible for PRIME (PRIority MEdicine) by the EMA for the treatment of primary HLH. In addition, on August 25th, 2017 a rare pediatric disease designation was granted by the FDA for emapalumab for the treatment of primary HLH. 

On 20th July 2018, Novimmune announced an agreement with Swedish Orphan Biovitrum (Sobi™) of Sweden for Sobi to acquire the global commercialization and development rights to emapalumab. The agreement is progressing through competition authority approvals and is expected to close Q3 2018.

 

About Hemophagocytic lymphohistiocytosis

Hemophagocytic Lymphohistiocytosis (HLH) is a clinical syndrome of hyperinflammation, driven by high interferon gamma (IFNγ) production, characterized by severe hyperferritinemia, fever, severe cytopenia, coagulation defects and organomegaly.

HLH occurs as a familial autosomal recessive disorder (primary HLH) or as an acquired, reactive condition (secondary HLH). Primary HLH typically arises in pediatric patients, is lethal if untreated, and has a 40% mortality rate with current best available care. The secondary form of the disease typically arises later in life, and is also associated with significant mortality. HLH is an orphan disease for which no drugs have been approved, representing a high unmet need.

 

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. More than 140 employees operate from two sites, Geneva and Basel, Switzerland. More information is available on the company website at www.novimmune.com.

Source: Novimmune