FDA News Roundup: AstraZeneca, Teva, Amgen, And More
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
What regulatory decisions did you miss this week?
Clanotech Glaucoma Drug Named Orphan Drug
α5β1-integrin antagonist and newly designated orphan drug CLT-28643 has demonstrated its ability to boost the healing process following glaucoma surgery in animal models because of its anti-angiogenic, anti-fibrotic, and anti-inflammatory properties.
Aduro Biotech Mesothelioma Drug Wins Orphan Designation
CRS-207 is an immunotherapy candidate that has already earned orphan drug designation for the treatment of pancreatic cancer. The drug is part of Aduro’s live-attenuated double-deleted Listeria monocytogenes immunotherapy platform. The company is currently testing the drug in combination with standard-of-care chemo in a Phase 1b clinical trial, and so far, patients taking CRS-207 have reported with a 94 percent rate of disease control — 75 percent had confirmed partial responses and 19 percent experienced a stable disease response.
FDA Accepts HIV Vaccine BLA For Review
Immune Response Biopharma’s BLA for Remune HIV/AIDS vaccine was accepted for review. The therapeutic vaccine, which contains killed HIV-1 virus particles emulsified by Incomplete Freunds Adjuvant, was designed to stimulate the immune system against the virus. In studies, the drug has demonstrated efficacy in improving percentage of CD4 cells, HIV-1 DNA in PBMCs, and weight. The drug can be taken alongside antivirals.
Adamis Injection Receives CRL
The FDA issued a Complete Response Letter to Adamis’ injection for severe allergic reactions because the agency was concerned about the volume of the dose in the pre-filled syringe. The FDA did not have any other concerns about the injection, which provides patients with two single dose syringes of epinephrine in the case of an allergic reaction.
ADA Therapy Earns Orphan Designation
Sigma Tau Pharma received orphan drug designation for its enzyme replacement therapy EXN-2279, which is indicated for adenosine deaminase (ADA) deficiency in patients with severe combined immunodeficiency. The therapy, currently in Phase 3 clinical trials, is a PEGylated recombinant version of the company’s ADA drug Adagen, which is currently available on the market.
Brilinta Gains Additional Administration Option Approval
AstraZeneca’s oral antiplatelet therapy Brilinta for acute coronary syndrome (ACS) is now approved to be crushed and mixed with water for patients who have trouble swallowing the 90mg tablets whole. This is a new administration option for P2Y12 inhibitors, which are not approved to be crushed for ease of administration. Brilinta is a part of a chemical class called cyclopentyltriazolopyrimidines.
Novartis’ Jadenu Tablets Win FDA Nod
The FDA has approved the once-daily oral iron chelator Jadenu — the new oral formulation of Exjade (deferasirox) — for children and adults with chronic iron overload following blood transfusions (ages 2+) or in non-transfusion-dependent thalassemia syndromes (ages 10+). The previous version of the drug Exjade needed to be mixed into a liquid and then swallowed on an empty stomach. Jadenu is swallowed whole and can be taken with or without food.
Protolax Drug Given Green Light To Launch Clinical Trial
The FDA’s Office of Hematology and Oncology Products has granted Protalex permission to launch a Phase 1 clinical trial of its PRTX-100 for Immune Thrombocytopenia (ITP) following review of the company’s IND. The treatment, which is a highly purified form of Staphylococcal Protein A, is currently under investigation as a treatment for rheumatoid arthritis following an IND submission to the Division of Pulmonary, Allergy, and Rheumatology Products. The company intends to launch the Phase 1/2 clinical study in the second half of this year. The company is optimistic following pre-clinical studies that the drug has the capacity to keep platelets safe from destruction by the immune system.
Amgen’s Myeloma Drug Granted Priority Review
Amgen’s recently acquired multiple myeloma drug Kyprolis received some positive feedback from the FDA this week when the agency granted its sNDA priority review. The company is attempting to expand the drug’s label to treat patients whose disease has relapsed following at least one prior therapy. The FDA will release its decision by the end of July. Kyprolis has been available on the market since 2012, indicated for patients with multiple myeloma who saw disease progression following two previous therapies, including Velcade and an immunomodulatory agent. The company has high hopes for the drug, considering recent Phase 3 results indicate the drug performed better than its competitor Velcade.
Idera Lymphoma Treatment Named Orphan Drug
IMO-8400, indicated for diffuse large B-cell lymphoma, was awarded orphan designation. The drug, an atagonist of the endosomal Toll-like receptors (TRL) 7,8, and 9, is currently under investigation in a clinical trial for patients with relapsed or refractory DLBCL presenting with MYD88L265P oncogenic mutation. TLR signaling is implicated in the survival and spread of tumors, and as a TRL antagonist, the drug aims to halt over-activated TRL signaling in B-cell lymphomas. In trials, the drug is being administered subcutaneously in three dose-escalation cohorts to determine its safety, tolerability, and clinical performance.
FDA Approves Teva Asthma Treatment
Teva’s ProAir RespiClick (albuterol sulfate) inhalation powder was approved for patients ages 12 and up suffering from reversible obstructive airway disease and exercise-induced bronchospasm (EIB). The treatment is a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist (SABA) inhaler and currently holds the record of the being the only dry-powder rescue inhaler to be approved for the treatment of asthma. The inhaler demonstrated its safety and efficacy in eight clinical trials enrolling asthma and EIB patients.