The US Food and Drug Administration has issued an authorization for several types of Jabla Small Molecule Immunotherapeutic Thrombin (JMSITH), manufactured by Moderna Therapeutics Inc. and Johnson & Johnson’s Janssen Research & Development LLC.
The approval expands the JMSITH products on the market in the US to include Thrombin, or sweat glands produced by the upper and lower immune system. Thrombin proteins protect against blood loss by binding to a protein called hemoglobin. Their action occurs within the human body.
“Moderna and Johnson & Johnson stand ready to provide specialty medicines to patients and to drive innovation in the diagnostics, therapeutics and clinical development of rare diseases,” said Dr. Ruth Puliseris, the CEO of Moderna Therapeutics.
The approval for Thrombin follows earlier approvals for the products Viibryd, a therapy for patients with schizophrenia, and bococizumab for patients with psoriasis, which are manufactured by Janssen. The company has nine partnered products including 11 more thrombin products, which are being developed independently, but which will ultimately be available with a manufacturing partner.
The infusion therapy will be approved in the US for adult patients with thrombocytopenia or reduced red blood cell count due to chronic bleeding or chemotherapy and for pediatric patients who have previously had thrombocytopenia (for example in a birth injury or being born with a low platelet count). It can also be used for patients who have cachexia, or excessive skeletal muscle wasting, caused by illnesses, conditions, or medications, for example an inflammatory bowel disease or chemotherapy.