Magazine article Drug Topics

New Products

Magazine article Drug Topics

New Products

Article excerpt

RX&OTC

RX CARE

New drugs

October saw simultaneous FDA approval of pirfenidone (Esbriet; InterMune) [1] in 267-mg capsules and nintedanib (Ofev; Boehringer Ingelheim) [2] in 150-mg capsules to treat idiopathic pulmonary fibrosis (IPF). Progressive lung scarring caused by IPF results in shortness of breath and severe coughing disruptive of normal living. According to FDA, treatments to date have included oxygen therapy, pulmonary rehabilitation, and lung transplant, making Esbriet and Ofev significant new treatment options. Both products will cost more than $90,000 per year, and will manage, not cure, the disease, requiring lifelong adherence. (www.esbriet.com; www.ofev.com)

Eisai has announced FDA approval of the fixed combination of netupitant 300 mg/palonosetron 0.5 mg [3] (Akynzeo) for the prevention of acute and delayed nausea and vomiting associated with chemotherapy treatment. There are no contraindications. Patients have reported some hypersensitivity reactions, including anaphylaxis, and adverse reactions have included headache, asthenia, dyspepsia, fatigue, constipation and erythema. Patients with severe hepatic or renal impairment should not use this product. (www.akynzeo.com)

FDA has approved ledipasvir 90 mg/ sofosbuvir 400 mg (Harvoni; Gilead Sciences), the first combination tablet for the treatment of chronic hepatitis C genotype 1 infection. The interferon- and ribavirinfree once-a-day therapy is expected to simplify treatment regimens. Three phase 3 trials demonstrated sustained virological response rates (no sign of vims six months after treatment) above 90%. Sofosbuvir, branded Sovaldi, is priced at $ 1,000/pill. The price tag for one tablet of Harvoni is $1,125; 24 weeks of treatment will run $189,000. Gilead Sciences is offering a patient-assistance program for patients who lack insurance coverage; for information, paste "Support Path for Sovaldi and Harvoni" into your browser. Harvoni is the third chug treating chronic HCV infection to win FDA approval in the past year. Simeprevir (Olysio) was approved in November 2013 and sofosbuvir in December 2013. (www.harvom.com)

Teva has announced that its beclomethasone dipropionate HFA with dose counter [4] (Qvar), approved in May, is now commercially available throughout the United States. …

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