Breakthrough therapy in Europe for Novimmune
Our expert's opinion
"The main activity of the Swiss Biotech Novimmune is to discover and develop medicines based on antibodies to treat inflammatory diseases, cancer and disorders related to our immune system. Their flagship product « Emapalumab » treats the patients touched by Hemophagocytic Lymphohistiocytosis (or HLH for short), who are mainly children (the article explains the gravity of this disease very well). Novimmune just submitted Emapalumab to the EMA in hope that it will be available in Europe soon. As early as March 2016, the FDA considered emapalumab as « a breakthrough therapy ». The product was eligible for use in « primary medicine » (PRIME, treatment of primary HLH) on top of another grant by the FDA for a rare pediatric disease. Overall, things are going well for Novimmune and we can hope that they perform their clinical trials in Belgium for their next products, so we can participate in the growth of this promising company."
- Antoine Desprez, Associate Consultant
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.
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.