Here: a quick look at newly approved agents for primary care that will soon be coming your way.
Juluca is a fixed-dose tablet containing 2 previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least 6 months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca. (Approved November 21, 2017, ViiV Healthcare)
Fasenra, (benralizumab) has been approved for the add-on maintenance treatment of patients with severe asthma aged 12 years and older who have an eosinophilic phenotype. It is not approved for treatment of other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus. Fasenra is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours, as observed in a Phase II study. (Approved 11/14/17, AstraZeneca)
Heplisav-B is approved for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. It is the first new hepatitis B vaccine in the US in more than 25 years and the only 2-dose hep B vaccine for adults. (Approved 11/9, Dynavax Technologies Corporation)
Shingrix (Zoster Vaccine Recombinant, Adjuvanted) is approved for prevention of shingles in adults 50 years and older. Shingrix is a non-live recombinant subunit vaccine administered IM in 2 doses. GSK reports that the vaccine has shown over 90% efficacy across all age groups. Shingrix combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age. (Approved 10/20/17, GlaxoSmithKline)
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The FDA has approved Zilretta (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for OA knee pain. The product provides a new non-opioid therapy that may help patients manage their OA pain for over 12 weeks via its proprietary microsphere technology. Zilretta's label also includes results from a double-blind, randomized, parallel-group trial, which examined blood glucose concentrations in patients with T2 diabetes. That trial showed that Zilretta may avoid disruptive blood glucose spikes that can occur with corticosteroid use in patients with knee OA and T2 diabetes. (Approved 10/6/17, Flexion Therapeutics, Inc.)
Ascor (Ascorbic Acid Injection, USP) is vitamin C indicated for short term (up to 1 week) treatment of scurvy in adults and children age 5 months and older for whom oral administration is not possible, insufficient, or contraindicated. Ascor is the first single moiety ascorbic acid drug approved for the US market and is the result of a multi-year development effort. It is provided in a 50 mL vial labeled as a Pharmacy Bulk Package with a strength of 500mg/mL. (Approved 10/2/17, McGuff Pharmaceuticals, Inc.)
Fiasp (insulin aspart), 100 Units/mL, is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Fiasp is a new formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in about 2.5 minutes. It can be dosed at the beginning of a meal or within 20 minutes after starting. Fiasp will be available in a pre-filled delivery device FlexTouch® pen and a 10 mL vial. (Approved 9/29/17, Novo Nordisk)
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is a combination of an inhaled corticosteroid, a LAMA, and a LABA, and is delivered once-daily in a dry powder inhaler. It is the first product approved in the US that combines 3 active molecules in a single inhaler for maintenance treatment of COPD, including chronic bronchitis and/or emphysema. It is not indicated for acute bronchospasm or asthma. The FDA-approved strength is FF/UMEC/VI 100/62.5/25 mcg. (Approved 9/18/17, GlaxoSmithKline)
Xhance (fluticasone propionate) nasal spray, 93 mcg, for intranasal administration, is designed to deliver medicine to targeted areas deep in the nose via the Exhalation Delivery System. Approved for use in patients 18 years of age and older. Up to 10 million Americans are estimated to have nasal polyps and accompanying symptoms. (Approved 9/18/17, Optinose)
Solosec (secnidazole) Oral Granules. 2g oral granules for treatment of BV in adult women. Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose. It is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the US. (Approved 9/18/17, Symbiomix Therapeutics)
Adzenys ER (amphetamine) Extended-Release Oral Suspension. This once-daily, XR liquid medication does not need refrigeration or reconstitution at the pharmacy level. It uses the same proprietary modified-release drug delivery technology as Adzenys XR-ODT, thereby providing clinicians the option to transition appropriate patients from liquid to ODT formulations. Both Adzenys ER and Adzenys XR-ODT are bioequivalent to Adderall XR. (Approved 9/15, Neos Therapeutics)
The fourth quarter of 2017 saw a flurry of new drug approvals from the FDA. Here’s a brief overview of agents for primary care that were newly approved or that were granted a new indication.