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Monthly News Roundup - November 2017

FDA Approves Juluca, a Novel 2-Drug Regimen for HIV-1 Infection

In November, the U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Juluca (dolutegravir and rilpivirine), a single-tablet, two-drug regimen of dolutegravir (Tivicay) and rilpivirine (Edurant). Juluca is the first complete treatment regimen containing only two drugs, instead of three or more, for HIV maintenance. Juluca is used in certain adults with suppressed HIV-1 virus on a stable medication regimen for at least six months, with no history of treatment failure and no resistance to the individual components of Juluca. In clinical trials, Juluca was effective in keeping the virus suppressed and was comparable to those who continued their current anti-HIV drugs.

Every 8-Week Fasenra Approved for Severe Eosinophilic Asthma

Eosinophilic asthma patients have limited treatment options and often rely on oral steroids to manage their symptoms, which can lead to serious side effects. This month, the FDA approved AstraZeneca’s Fasenra (benralizumab), an interleukin-5 receptor monoclonal antibody used as an add-on maintenance treatment for severe eosinophilic asthma. It’s given as a subcutaneous injection once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter. In studies, Fasenra reduced the annual asthma exacerbation rate by up to 51% compared to placebo, and significantly reduced oral steroid use. Adverse events include headache, fever, sore throat and allergic reactions.

Vyzulta: A Dual Mechanism Prostaglandin Analog Approved for Glaucoma

The FDA has now approved Valeant’s Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%), a once-daily treatment for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. Vyzulta is the first nitric-oxide donating prostaglandin F2α analog for ophthalmic use. The eye drop works by breaking down into two metabolites: latanoprost acid and butanediol mononitrate, both of which help to increase the outflow of aqueous humor. Commonly reported side effects include conjunctival hyperemia (redness), eye irritation or pain. Increased pigmentation of the iris and periorbital tissue and growth of eyelashes can also occur.

First-In-Class Hemlibra is Cleared for Hemophilia A with Inhibitors

Hemlibra (emicizumab-kxwh), from Genentech, is a bispecific factor IXa- and factor X-directed antibody now approved to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A with inhibitors who have developed antibodies called Factor VIII (FVIII) inhibitors. Hemophilia A is an inherited blood-clotting disorder that primarily affects males. Hemlibra is a first-in-class subcutaneous injection that works by bridging other factors in the blood to restore blood clotting. In two clinical studies, there was an 87 percent reduction in the rate of bleeds that needed treatment. Common side effects include injection site reactions, headache, and joint pain (arthralgia).

Abilify MyCite: Swallowed Sensor Tracks If You’ve Taken Your Med

The cost of patient nonadherence -- not following a prescribed medical regimen -- has been estimated to be in the billions of dollars of avoidable US health care costs each year. The FDA has now approved Otsuka’s Abilify MyCite (aripiprazole), an atypical antipsychotic for schizophrenia, bipolar I disorder, and depression in adults. The Abilify tablet formulation is embedded with the ingestible Proteus sensor that allows patients, and, if given access, doctors and caregivers, to track ingestion of the medication on a smartphone or web-based portal. The system sends a message from the pill’s sensor to a wearable patch on the patient, which then transmits to the device.

Posted: November 2017