Drugs

Infectious Disease Designation for RedHill Therapy

FDA has granted RedHill Biopharma a Qualified Infectious Disease Product (QIDP) designation for RHB-104 and its use in treating Nontuberculous Mycobacteria (NTM) infections. The QIDP designation was granted under the Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for treating serious or life-threatening infections. RHB-104 is a proprietary antibiotic combination therapy in an oral capsule formulation that the company says has “potent intracellular, anti-mycobacterial and anti-inflammatory properties.”

NTM infections can occur throughout the body, although pulmonary infections, lymphadenitis, and skin and soft tissue infections are the most commonly affected areas, according to the company. There are a number of risk factors that can increase a person’s chances of acquiring the infections, including a history of bronchiectasis, chronic obstructive pulmonary disease, smoking, HIV/AIDS, use of immunosuppressive drugs and certain genetic conditions, such as cystic fibrosis and alpha-1 antitrypsin deficiency.

RedHill is currently conducting a Phase 3 study with RHB-104 for treating Crohn’s disease (MAP US study). “The development of RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease, and potentially other autoimmune diseases, are related to Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients,” it says. Recently, a Phase 2a, proof-of-concept clinical study evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing remitting multiple sclerosis (the CEASE MS study) was completed. ôTop-line final results from the CEASE MS study suggest meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development,” it adds.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome