FDA Update: August 2016

Aug 4, 2016
As a follow up to our preview of this blockbuster year for drug approvals, here are some recent updates to the drug pipeline.
Tags
  • Diabetes
  • High Blood Pressure/Heart Disease
  • Hepatitis C
Rph Article

Through a deep understanding of the drug pipeline and patent expirations, Express Scripts Office of Clinical Evaluation and Policy helps to provide drug policies that assure medically appropriate, unbiased and defensible clinical programs for plan sponsors.

Each year, we share a look at the year ahead so plan sponsors can better understand the drug pipeline and its impact. Here are some of the most recent approvals and updates we’re tracking:

Viekira XR Approved for Genotype 1 Hepatitis C

On July 25, 2016, the U.S. Food and Drug Administration (FDA) approved Viekira XR™, an extended-release formulation of dasabuvir/ombitasvir/paritaprevir/ritonavir tablets. It is indicated to treat adults who have chronic genotype 1 hepatitis C virus (HCV) infection. Dosing is three tablets taken once a day along with a meal. For patients who have genotype 1a HCV infection, Viekira XR will be used along with ribavirin. Recommended length of therapy for genotype 1a patients with compensated cirrhosis (Child-Pugh A) is 24 weeks; for genotype 1a patients without cirrhosis, treatment duration is 12 weeks. Patients with genotype 1b HCV infection without cirrhosis or compensated cirrhosis will take Viekira XR for 12 weeks and they will not need to use ribavirin. Patients with decompensated cirrhosis or severe liver conditions (Child-Pugh B or C) should not take it. AbbVie expects Viekira XR to be in pharmacies by the end of this week, but its cost has not yet been announced. Complete prescribing information can be found here.

Adlyxin Approved for Diabetes

On July 28, Sanofi received approval from the FDA for Adlyxin™ (lixisenatide). The drug is a glucagon-like peptide-1 (GLP-1) agonist for treating adults with type 2 diabetes; it is self-administered as a once-daily subcutaneous injection. The initial dose of Adlyxin is 10mcg once daily for 14 days and then increased to 20mcg daily. Prescribing information for Adlyxin is available here.

Qbrelis Approved for High Blood Pressure

On July 29, FDA approved Silvergate Pharmaceuticals’ Qbrelis™ (lisinopril oral solution) to treat high blood pressure in adults and children at least six years of age. It is also approved for use as an adjunct (add-on) therapy for heart failure and treatment of acute myocardial infarctions (heart attacks). Qbrelis is the first oral liquid formulation of the angiotensin-converting enzyme (ACE) inhibitor, lisinopril. It will be available in a 150 mL bottle containing 1 mg/mL of lisinopril solution. Silvergate Pharmaceuticals has not released pricing information or an expected launch date. Full prescribing information can be found here.

MedWatch Update: Fluoroquinolone Antibiotics

The FDA is strengthening its previous safety warnings for systemic (oral and injected) fluoroquinolone (quinolone) antibiotics. Some patients taking or injecting a quinolone have experienced anaphylaxis (a severe allergic reaction), intestinal infections, nerve damage, ruptured tendons, seizures, vision loss and other rare, but serious, adverse effects. Because they can cause such often irreversible problems, oral and injected quinolones generally should be reserved only for severe infections, such as anthrax and plague. The risks of using quinolones are too great for them to be used routinely for patients with uncomplicated acute bronchial, sinus and urinary tract infections. An oral or injected quinolone should only be used for uncomplicated infections when all other treatment options have failed. FDA is requiring revisions to boxed warnings, other label sections and patient Medication Guides for ciprofloxacin (Cipro®, generics) extended-release oral tablets, oral suspension, oral tablets and solution for injection; gemifloxacin (Factive®, generics) oral tablets; levofloxacin (Levaquin®, generics) oral solution, oral tablets and solution for injection; moxifloxacin (Avelox®, generics) oral tablets and solution for injection; and ofloxacin oral tablets. Patients, caregivers and healthcare providers should be alert for symptoms, such as arrhythmias, light sensitivity, numbness, rashes and weakness in the arms or legs, among patients using a systemic quinolone. The latest FDA Safety Communication along with information from prior warnings can be found here.

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