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The FDA has approved Furoscix (furosemide injection) a loop diuretic used for the at- home treatment of adults with congestion due to fluid overload in chronic heart failure.

scPharmaceuticals Inc., focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, announced that the U.S. Food and Drug Administration (FDA) has approved Furoscix (furosemide injection), a proprietary formulation of furosemide delivered via an on-body infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure.

Furoscix demonstrated 99.6% bioavailability and produced similar diuresis and natriuresis compared to intravenous furosemide. Furoscix is not indicated for emergency situations or in patients with acute pulmonary edema. The Furoscix infusion will last about 5 hours. Furoscix Infusor will deliver only an 80- mg dose. Furoscix is the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via the Furoscix Infusor.

The U.S. Food and Drug Administration on Friday allowed the use of GlaxoSmithKline’s (GSK.L) Boostrix vaccine during the third trimester of pregnancy to prevent whooping cough in infants younger than two months of age.

“When the Boostrix vaccine is given during pregnancy, it boosts antibodies in the mother, which are transferred to the developing baby,” the agency said.

While FDA’s approval of Boostrix has always included its use during pregnancy to protect the vaccinated individual, the latest decision expands its use to help prevent pertussis, commonly known as whooping cough, in infants younger than two months.

Alnylam has announced FDA approval of supplemental new drug application for Oxlumo (lumasiran) in advanced primary hyperoxaluria type 1.

The leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved a label expansion for Oxlumo^® (lumasiran), an RNAi therapeutic administered via subcutaneous injection, now indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients.

Oxlumo is administered once a month for three months, then monthly for patients weighing less than 10 kg, and quarterly for patients weighing more than 10 kg.

The most common adverse reaction (reported in ≥20% of patients) is injection site reactions.

Theratechnologies’ Trogarzo (ibalizumab-uiyk), an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body, has been approved by the FDA for 30-Second Intravenous (IV) Push, simplifying HIV treatment for heavily treatment-experienced population.

Trogarzo is used to treat the small percentage of patients who have multidrug-resistant human immunodeficiency virus type 1 HIV (MDR HIV-1 Infection) and who have failed other HIV therapies. In a clinical trial, most patients (33 of the 40 patients, or 83%) experienced a significant decrease in their HIV-RNA levels one week after Trogarzo was added to their ineffective antiretroviral regimens.

Trogarzo is administered intravenously (IV) once every 14 days by a trained medical professional

Catalyst Pharmaceuticals CPRX announced that the FDA approved its supplemental new drug application (sNDA) for Firdapse (amifampridine) tablets in 10 mg dosage to include pediatric patients (six years and older) for treating Lambert-Eaton myasthenic syndrome (“LEMS”).

The company submitted an sNDA to the FDA for the use of Firdapse in treating pediatric LEMS patients in the first quarter of 2022. LEMS is an ultra-rare disease autoimmune disorder characterized by muscle weakness of the limbs. Post the sNDA approval by the FDA, Firdapse is now a treatment option in the United States for all LEMS patients beyond six years of age.

Firdapse (amifampridine phosphate) is a nonspecific, voltage-dependent, potassium (K+) channel blocker for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in adults and pediatric patients six years of age and older.

The FDA approved Relyvrio, a drug developed by Amylyx Pharmaceuticals, after extensive discussions about the safety and efficacy of the drug. Used to treat adults with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease, the drug was initially rejected by an FDA advisory panel in March of this year. Earlier this month, the panel reconvened and reanalyzed, voting in favor of Relyvrio after being presented with additional data. The final ruling was delivered on September 29, 2022.

“FDA approval of Relyvrio is an exciting milestone for the ALS community and is a major step toward achieving our mission to one day end the suffering caused by neurodegenerative diseases,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx.

The U.S. Food and Drug Administration (FDA) granted accelerated approval to LYTGOBI (futibatinib) for the treatment of adult patients with previously treated, bile duct cancer that has spread or cannot be removed by surgery. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The approved recommended dosage of LYTGOBI is 20 mg orally (five 4 mg tablets) once daily until disease progression or unacceptable toxicity occurs. It is used in patients who have already received a previous treatment, and whose tumor has a certain type of abnormal FGFR2 gene. The tablets can be taken with or without food and swallowed whole, at approximately the same time each day.

Additional information regarding dosage and administration as well as warnings and precautions about ocular toxicity, hyperphosphatemia and soft tissue mineralization, and embryo-fetal toxicity can be found in the full prescribing information.

The U.S. Food and Drug Administration approved Regeneron/Sanofi’s Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis (PN). Dupixent is the first medication approved for PN, a rare inflammatory skin condition that can cause severe itching and have a significant negative impact on sleep and quality of life.

• Dupixent is an anti–interleukin (IL)-4 and anti–IL-13 biologic that was first approved to treat moderate to severe atopic dermatitis in 2017 and has since gained additional indications to treat several other type 2 inflammatory-driven conditions, such as asthma.

• In the Phase 3 PRIME and PRIME2 clinical trials, patients receiving Dupixent experienced superior itch reduction and achieved higher rates of clear or almost clear skin at 24 weeks compared with patients receiving placebo.

• IPD Analytics recommends prior authorization (PA) for Dupixent in the treatment of PN with a step through at least one medium- to super high-potency topical corticosteroid (TCS). Additionally, the PA criteria should match the labeled age and indication for PN. IPD also recommends including certain inclusion criteria from the PRIME and PRIME2 trials in the PA criteria.

• Utilization management of Dupixent should be high on payers’ radar, as utilization of the drug is expected to continue to grow for at least the next 5 years and biosimilar competition likely will not reach the market until 2031.

Celltrion USA announced that the U.S. Food and Drug Administration (FDA) has approved Vegzelma (bevacizumab-adcd), an anti-cancer monoclonal antibody treatment and a biosimilar to Avastin (bevacizumab), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Vegzelma is a recombinant humanized monoclonal antibody which binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2), on the surface of endothelial cells.

The FDA approval of Vegzelma was based on the totality of evidence, including the pivotal phase III trial in patients with metastatic or recurrent nsNSCLC. Results showed that as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.

The FDA has approved chloroprocaine hydrochloride ophthalmic gel 3% (Iheezo; Harrow) for use as an ocular surface anesthesia. Iheezo is a sterile, single-use ophthalmic gel preparation administered by physicians. The treatment contains no preservatives and is safe and effective for ocular surface anesthesia, according to a Harrow press release.

• Iheezo is the first ophthalmic formulation of chloroprocaine hydrochloride, an anesthetic previously approved in injectable formulations under the brand names Nesacaine/Nesacaine- MPF for local anesthesia and Clorotekal for spinal anesthesia.
• This surface anesthesia is contraindicated in patients who have a history of hypersensitivity to any component of the medication. The drug should not be injected or administered intraoculary.
• Iheezo is physician-administered topically to the ocular surface prior to the planned surgical procedure. It is rapidly acting (about 1 to 5 minutes) and the anesthetic effect lasts around 20 minutes.
• The most common adverse reaction is mydriasis.
• Given the early FDA approval date, the commercial launch date for Iheezo will be slightly ahead of the original planned launch of May 2023.