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Weekly Drug News Round-Up: November 15, 2017

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

The system sends a message from the pill’s sensor to a wearable patch, which then transmits to a smartphone Read More...

Patient nonadherence -- not following through on a prescribed medical regimen -- has been estimated to be in the hundreds of billion of dollars of avoidable U.S. health care costs, each year. This week, the FDA approved Otsuka’s Abilify MyCite (aripiprazole), an atypical antipsychotic for schizophrenia, acute bipolar I disorder, and as an add-on therapy for depression in adults. The Abilify tablet formulation is now embedded with the ingestible Proteus sensor that allows patients -- and if given access -- doctors and caregivers, to track the ingestion of the medication on their smartphone or web-based portal. However, improvements in patient compliance with Abilify MyCite’s are not yet documented. Plus, the price for Abilify MyCite isn’t reported either.

Every 8-Week Fasenra Approved for Severe Eosinophilic Asthma

Fasenra is given initially as a subcutaneous injection once every 4 weeks for the first 3 doses, then once every 8 weeks Read More...

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 week, the FDA approved AstraZeneca’s Fasenra (benralizumab), an interleukin-5 receptor monoclonal antibody used as an add-on maintenance treatment for severe eosinophilic asthma. In studies, Fasenra reduced the annual asthma exacerbation rate by up to 51% compared to placebo. Other results included a significant improvement in lung function (FEV1), a 75% median reduction in use and a 52% discontinuation rate of oral steroids, and a favorable side effect profile.

FDA Approves Two Dose Heplisav-B for Hepatitis B Prevention

The most common side effects include injection site pain, fatigue, and headache Read More...

In 2015, new cases of acute hepatitis B, an infectious and potentially deadly liver virus, increased by more than 20% nationally. However, hepatitis B, which spreads through contact with infected blood, can be prevented with vaccination. The FDA has now approved Dynavax’s Heplisav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Heplisav-B is the first new hepatitis B vaccine in the US in more than 25 years and the only two-dose hepatitis B vaccine for adults.

Polysorbate 80-Free Cinvanti Cleared for Chemo-Induced Nausea, Vomiting

Polysorbate 80 free has been linked to hypersensitivity reactions, including anaphylaxis Read More...

Cinvanti (aprepitant) is a polysorbate 80-free, intravenous (IV) formulation of aprepitant, a substance P/neurokinin-1 (NK 1) receptor antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV), in both the acute and delayed phase. Cinvanti, from Heron Pharmaceuticals, is the first IV formulation to directly deliver aprepitant, the active ingredient found in Emend capsules. Cinvanti reduces CINV in both the acute and delayed phases of treatment. Cinvanti was approved based on data demonstrating the bioequivalence of Cinvanti to Emend IV (fosaprepitant). Cinvanti is expected to launch in January 2018.

Once-Daily Prevymis OK'd for Prevention of Cytomegalovirus (CMV)

Transplant recipients who develop CMV infection are at increased risk for transplant failure and death Read More...

Cytomegalovirus (CMV) is a potentially serious viral infection in patients who have received an stem-cell transplant from a matching donor (allogeneic). This past week the FDA approved Merck’s Prevymis (letermovir) for prevention of CMV infection in this group. Prevymis is a non-nucleoside CMV inhibitor that blocks viral replication by targeting the viral terminase complex. In pivotal studies, significantly fewer patients in the Prevymis group (38%, n=122/325) compared to the placebo group (61%, n=103/170) developed CMV infection or discontinued treatment. Prevymis was approved in two dose forms: once-daily oral tablets and an injection for intravenous infusion.

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