FDA Updates Archives - Page 5 of 6

FDA approves TAVR System in severe AS

The US Food and Drug Administration has approved Medtronic’s Evolut FX system for transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis at all risk levels. The Evolut FX system features a self-expanding, supra-annular valve and is designed to enhance ease-of-use and provide greater precision and control throughout the procedure. The fourth-generation device is equipped with gold markers built into the frame to provide direct visualization of depth and valve leaflet location during implant.

Source: Medscape

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FDA has expanded indication for the noninvasive Deep TMSTM

The US Food and Drug Administration (FDA) has expanded indication for the noninvasive BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMSTM) System to include treatment of comorbid anxiety symptoms in adult patients with depression, the company has announced. The neurostimulation system has previously received FDA approval for treatment-resistant major depression, obsessive-compulsive disorder, and smoking addiction.

Source: Medscape

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FDA approves spinal cord stimulation for diabetic neuropathy pain

The Food and Drug Administration has approved the first high-frequency spinal cord stimulation (SCS) therapy for treating painful diabetic neuropathy (PDN).

The approval is specific for the treatment of chronic pain associated with PDN using the Nevro’s Senza System with 10 kHz stimulation. It is intended for patients whose pain is refractory to, or who can’t tolerate, conventional medical treatment.

The 10 kHz device, called HFX, involves minimally invasive epidural implantation of the stimulator device, which delivers mild electrical impulses to the nerves to interrupt pain signal to the brain. Such spinal cord stimulation “is a straightforward, well-established treatment for chronic pain that’s been used for over 30 years,” according to the company, although this is the first approval of the modality specifically for PDN.

Source: Medscape

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FDA approves Finerenone for slowing CKD in T2DM

The FDA approved the anti-mineralocorticoid agent finerenone (Kerendia) for slowing the progression of chronic kidney disease in type 2 diabetes patients.

The first non-steroidal, selective mineralocorticoid receptor antagonist was approved to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

The most common adverse events in the trial were hyperkalemia (18% vs 9% for those on placebo), hypotension, and hyponatremia. Finerenone should therefore not be used if serum potassium is above 5.0 mEq/L. Serum potassium and eGFR should also be measured in all patients prior to and during treatment and should be dosed according to these measures.

Source: FDA

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Lenvatinib-Pembrolizumab combo promising in advanced kidney cancer

The combination of the multikinase inhibitor lenvatinib and the anti-PD-1 antibody pembrolizumab has “encouraging” antitumor activity and a manageable side effect profile and might be an option following immune-checkpoint inhibitor (ICI) therapy in patients with metastatic renal-cell carcinoma (RCC), researchers report.

Pembrolizumab and lenvatinib are active as monotherapies in RCC. The phase-1b/2 Study 111/KEYNOTE-146 trialists tested the combination in 145 patients with metastatic RCC. Two patients with non-clear-cell RCC were excluded from the efficacy analysis but included in the safety analysis.

Source: Reuters Health

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FDA approves first oral anticoagulant for children

The US Food and Drug Administration (FDA) has approved dabigatran etexilate (Pradaxa) oral pellets for the treatment of venous thromboembolism (VTE) in children aged 3 months to less than 12 years. The drug is to be administered immediately after patients have completed a 5-day course of an anticoagulant given by injection.

The most common side effects include digestive system symptoms and bleeding. Dabigatran etexilate can cause serious and fatal bleeding and is not recommended for patients with bioprosthetic heart valves or triple-positive antiphospholipid syndrome.

A boxed warning cautions that stopping treatment early may increase the risk for clots and that spinal or epidural hematomas in patients undergoing spinal procedures may cause serious side effects.

Dabigatran etexilate was originally approved in 2010 for adults with nonvalvular atrial fibrillation to reduce risk for stroke and systemic embolism.

Source: FDA

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FDA approves StrataGraft for deep skin burns

The US FDA has approved a novel regenerative therapy that could be an alternative to autografting for treating adults with severe burns. The new treatment, StrataGraft, is a bilayer tissue-engineered to mimic the epidermal and dermal layers of the human skin and act as a scaffold for a burn patient’s own skin cells to grow and heal.

The approval was based on the results of two randomized clinical trials (NCT01437852 and NCT03005106) that demonstrated the effectiveness and safety of StrataGraft in 101 adult patients with deep partial thickness thermal burns. These are burns caused by contact with an external heat source such as steam that results in damage throughout the epidermis and dermis.

Source: FDA

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FDA approves Brincidofovir to treat smallpox

The US FDA has approved Chimerix’s brincidofovir (BCV, Tembexa) to treat smallpox. Fearful of a possible bioweapon attack, the United States has been steadily preparing a defense through the Biomedical Advanced Research and Development Authority. BCV is neither a new nor unknown drug. It is a lipid conjugate of cidofovir, a drug used to treat cytomegalovirus (CMV) in patients with AIDS.

Dose:

≥48 kg (tablet or oral suspension): 200 mg PO qWeek x 2 doses (on Days 1 and 8)
<48 kg (oral suspension): 4 mg/kg PO qWeek x 2 doses (on Days 1 and 8)

Adverse Effect: Diarrhea (8%), Nausea (5%), Vomiting (4%), Serum creatinine elevated (>1.5-3x ULN) (4%), Abdominal pain (3%), ALT elevated (>3 to 20x ULN) (2-3%), Total bilirubin elevated (>1.5 to 10x ULN) (1-3%), AST elevated (>3 to 20x ULN) (1-2%)

Tecovirimat was the first drug for smallpox, approved in 2018.

Source: FDA

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FDA approves new drug treatment for chronic weight management

The US FDA approved Wegovy (semaglutide) injection a GLP-1 receptor agonists (2.4 mg once weekly SC) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced-calorie diet and increased physical activity.

The drug is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater.

Side effects: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation (belching), hypoglycemia in patients with type 2 diabetes, flatulence (gas buildup), gastroenteritis and GERD.

Warning: risk of thyroid C-cell tumors, not to be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Source: FDA

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FDA approves first drug for lung cancer with KRAS mutation

Sotorasib (Lumakras), specifically targets the KRAS G12C mutation, which accounts for about 13% of NSCLC mutations. KRAS mutations are the most common mutations to occur in NSCLC tumors, accounting for about 25% of them, but for a long time, they appeared to be resistant to drug therapy.

Dose: 960 mg once daily

Side effects: The most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. The most common laboratory abnormalities (≥ 25%) were decreased lymphocytes, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium.

Contraindications: Interstitial lung disease, CLD, along with drugs that are substrates of the P-glycoprotein.

Source: FDA