Posts in category: Business

FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra

Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has approved Tyenne® (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra® (tocilizumab). Tyenne becomes the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA. In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the U.S. commencing on the license dates, which are confidential.

Tyenne has launched globally in more than 10 countries, with plans to launch in many more countries between 2024 and 2025. Tyenne (tocilizumab-aazg) is FDA approved for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Read more…

FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva

Sandoz, announced that the U.S. Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeable biosimilar to Xgeva. Wyost is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

Read more…

FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lines

Hugel America, Inc., a division of Hugel Inc., today announced it received U.S. Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe glabellar (frown) lines in adults. In the coming months, Hugel plans to accelerate its transition for approved medical use with the goal of launching to aesthetic clinicians in the back half of 2024.

FDA approval is supported by positive results from three completed phase III trials that enrolled more than 1,000 subjects in the U.S. and Europe. This botulinum toxin type A has been the leading neurotoxin brand in South Korea, one of the world’s most dynamic aesthetic markets, for seven consecutive years. Hugel has sold over 26 million vials in 50+ different countries including Australia, Canada, and Europe.

Read more…

FDA Approves Exblifep for the Treatment of Complicated Urinary Tract Infections

Allecra Therapeutics (“Allecra”) announced that the U.S. Food and Drug Administration has approved Exblifep as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older. Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act). The GAIN Act, enacted by the U.S. Congress, incentivizes the creation of new anti-infective therapeutics by providing benefits to manufacturers of Qualified Infectious Disease Products (QIDPs).

Exblifep is a combination antibiotic used for complicated urinary tract infections (cUTIs) that contains two antibiotics, cefepime and enmetazobactam. Exblifep is used when the bacteria causing the UTI is resistant to other antibiotics, especially if the resistance is due to Extended Spectrum Beta Lactamases (ESBLs).

Read more…

FDA Approves Aurlumyn (iloprost) as the First Medication to Treat Severe Frostbite
The U.S. Food and Drug Administration (FDA) approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. The FDA granted the approval of Aurlumyn to Eicos Sciences Inc.

Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation. Iloprost, the active ingredient in Aurlumyn, is a vasodilator (a drug that opens blood vessels) and prevents blood from clotting.

Read more…

FDA Approves Loqtorzi (toripalimab-tpzi) in All Lines of Treatment for Recurrent or

Metastatic Nasopharyngeal Carcinoma (NPC)

Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. have announced that the U.S. Food and Drug Administration (FDA) approved Loqtorzi™ (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum containing chemotherapy. The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status. Loqtorzi is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor. NPC is an aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. Loqtorzi is the first FDA-approved agent for NPC patients.

The recommended Loqtorzi dose with cisplatin and gemcitabine is 240 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months. The recommended Loqtorzi dose as a single agent for previously treated NPC is 3 mg/kg every two weeks until disease progression or unacceptable toxicity. Loqtorzi is expected to be available in the United States in Q1 2024.

Read more…

Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples.

Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Exela has not received any reports of adverse events related to this recall.

8.4% Sodium Bicarbonate Injection USP is used for treatment of metabolic acidosis and is packaged in a 50 mL glass single dose vials, 20 vials per carton Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and 25 vials per carton Exela brand (Carton NDC: 51754-5001-4; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-01, Figure 2). The affected 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

Product was distributed nationwide to wholesalers, distributors, and health systems between January 18,
2022, and February 15, 2023.

FDA Approves Zituvio (sitagliptin) for the Treatment of Adult Patients with Type 2 Diabetes Mellitus
Zydus Lifesciences has announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Zituvio (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg. Zituvio contains active ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Zituvio is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Zituvio is not recommended in patients with type 1 diabetes mellitus. Zituvio has not been studied in patients with a history of pancreatitis.

Read more…

FDA Approves Velsipity for Moderate-to-Severe Ulcerative Colitis in Adults

The U.S. Food and Drug Administration approved Velsipity (etrasimod) for adults with moderately to severely active ulcerative colitis (UC). Velsipity provides adults living with moderately-to- severely active UC the opportunity to achieve steroid-free remission with an oral, once-daily pill. Approval of Velsipity was granted to Pfizer.

The approval was based on results from the ELEVATE UC phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that included UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase inhibitor therapy. In ELEVATE UC 52, 27.0 percent of patients receiving Velsipity achieved clinical remission versus 7.0 percent of patients receiving placebo at week 12, and at week 52, clinical remission was achieved by 32.0 and 7.0 percent, respectively. In ELEVATE UC 12, 26.0 percent of patients receiving Velsipity achieved clinical remission versus 15.0 percent of patients receiving placebo. At week 12, all key secondary efficacy end points were met, including endoscopic improvement and mucosal healing.

The selective sphingosine-1-phosphate receptor modulator was approved at a 2mg recommended dose. The safety of Velsipity was consistent with previous studies, with the most common adverse reactions being headache, elevated liver tests, and dizziness (incidence ≥5 percent).

Read more…

FDA Approves Technegas® (Technetium Tc 99-m Labeled Carbon) Radioactive Diagnostic Agent

Cyclopharm Limited announced the company has received U.S. Food and Drug Administration (FDA) approval to commence commercial sales of Technegas® in the US market. The approval opens for Cyclopharm the single largest market for Technegas globally, and one which the company estimates to be initially worth approximately $180 million annually for the diagnosis and management of Pulmonary Embolism (PE).

• Strong pre-existing demand expected to drive sales momentum for an immediate US wide rollout.

• Approval allows for broad use of Technegas, supporting wider future indications across other
respiratory disease states including Chronic Obstructive Pulmonary Disease (COPD), Asthma, Long
COVID and lung cancer.

Read more…