Pulse Newsletter
Your source for the latest industry trends and drug information news.
Volume 1 | Issue 3
March 1, 2019
Contributors:
Chief Author: Kevin Lavery, PharmD
Editor: Dana Ranallo, PharmD
Clinical Update
Influenza activity hits highest level this season
The Centers for Disease Control and Prevention (CDC)’s weekly FluView report revealed that flu incidence has reached a season high for the week ending February 16, 2019. The proportion of people seeking treatment for influenza-like illness (ILI) reached 5.1%, up from 4.8% the week preceding, and far above the national baseline of 2.2%. However, these rates remain well below 7.5% seen in the 2017-2018 season. The CDC estimates on average, 5 to 20 percent of the U.S. population gets the flu each season and tens of thousands of people are hospitalized each year. This is estimated to cost the U.S. healthcare system $10.4B a year in direct medical expenses from hospitalizations and outpatient visits.
Safety First
Serious adverse events rare for Shingrix™, says CDC report
Researchers from the CDC concluded in a recent report that the ongoing post-release safety monitoring of adverse events for Shingrix™, new shingles vaccine approved in October 2017, has seen similar rates of adverse events as those during pre-release studies. It was found that of the roughly 3.2 million doses of the vaccine administered during the first 8 months of use, 4,381 adverse events were reported, including fever, injection-site pain, and injection-site redness. Only 3% of the adverse reactions were considered serious. The efficacy and success of Shingrix™ has far surpassed that of the previous standard of care for shingles by 27-53%, resulting in decreases in hospital admissions and long-term side effects caused by the debilitating disease. The CDC guidelines recommend those aged 50 or older receive two doses of Shingrix™, spaced 2-6 months apart.
From the Industry
High-tech capsule to revolutionize drug injections
Scientists at MIT, Harvard, and Novo Nordisk have developed a tiny robotic capsule that injects insulin once it lands in the stomach. The device is modeled after the angled shell of a leopard tortoise–which always rights itself after rolling over–to ensure the capsule lands in the stomach in a desired fashion to enable the drug to be absorbed as effectively as possible. Oral administration of medication has always presented challenges in drug development due to the potential for drug degradation and breakdown. If successful, this device would provide a novel mechanism for insulin to be administered orally while preventing breakdown in the stomach and ultimately minimizing the need to inject insulin using needles, syringes, and injection pens. With the completion of successful testing in laboratory models, researchers hope to begin human testing within 3 years.
FDA Approvals
Recent FDA Approvals
2 novel drugs approved:
Egaten® (triclabendazole):
Oral tablet for the treatment of parasitic infections known as fascioliasis in patients 6 years and older [2/13/19 – Orphan Drug; Priority Review – NOVARTIS PHARMS CORP]
Injection for the treatment of a rare and life-threatening blood clotting disorder known as aTTP [2/6/19 – BLA; Orphan Drug; Priority Review – ABLYNX NV]
New Generics
New Generics Entering the Marketplace
buprenorphine/naloxone (Suboxone® Film)
Indication: Opioid Dependence
Dosage Form/Strength: 2-0.5MG, 4-1MG, 8-2MG, 12-3MG sublingual film
Average Wholesale Price (AWP): Generic = $264/30 day supply (DS) | Brand = $308/30 day supply (DS)
Wixela™ Inhub™(Advair® Diskus)
Indication: Asthma/COPD
Dosage Form/Strength: 100, 250, or 500mcg fluticasone propionate and 50mcg salmeterol for oral inhalation Average Wholesale Price (AWP): Generic = $361 (100mcg), $449 (250mcg), $590 (500mcg)/30 day supply (DS) | Brand = $317 (100mcg), $393 (250mcg), $518 (500mcg)/30 day supply (DS)