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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 3 | Issue 10
May 15, 2021

Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Farxiga® to Slow Progression of CKD

On April 30, 2021, the U.S. Food and Drug Administration (FDA) approved Farxiga® (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, hospitalization for heart failure, and cardiovascular death in adults with chronic kidney disease (CKD) at risk of disease progression. Farxiga®, originally approved in 2014 for the treatment of adult patients with type 2 diabetes, belongs to a class of drugs known as sodium-glucose cotransporter-2 inhibitors (SGLT2-i). It works to help lower blood sugar in diabetic patients by causing the body to eliminate it through urination. Taking Farxiga® also alters how sodium is reabsorbed in the kidneys, and for patients with heart failure and CKD, this has shown to result in a reduction of how hard the heart needs to work when pumping blood throughout the body as well as the pressure within the kidneys. The label expansion comes after the release of results from a Phase III trial including 4,304 adult patients with advanced CKD who were treated with either Farxiga® or placebo along with standard of care for patients with CKD. The Farxiga® group demonstrated a 39% risk reduction when compared to placebo in preventing worsening of renal function, onset of end stage renal disease (ESRD) or risk of cardiovascular or renal death, regardless of whether or not a participant had type 2 diabetes. This new indication for Farxiga® received Fast TrackBreakthrough Therapy, and Priority Review designations from the FDA.

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Drug Safety

NP Thyroid® Recall Due to Sub Potency

On April 30, 2021, the FDA posted an announcement regarding Acella Pharmaceuticals’ voluntary recall of certain lots of NP Thyroid® oral tablets after routine testing found the lots to be sub potent. NP Thyroid® is approved for use as replacement or supplemental therapy in patients with hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone as a result of various root causes. Thyroid hormone plays a role in the regulation of body temperature, heart rate and metabolism. Deficiency in thyroid hormone can lead to these regulatory processes slowing down and can cause symptoms such as increased sensitivity to cold, fatigue, forgetfulness, weight gain and constipation. Pregnant women with hypothyroidism may face risks such as early miscarriage, fetal hyperthyroidism and/or impairments to fetal neural and skeletal development. Affected lots were distributed nationwide to Acella’s direct accounts, wholesalers, pharmacies and health care offices. Acella has asked distributors to stop allocation of the affected lots and is arranging for return of all recalled products. Individuals who are currently taking NP Thyroid® are advised to not change the way they are taking their medication without first talking to their health care provider. As of April 30, 2021, Acella had received 43 reports of serious adverse events that could be related to this recall, and anyone who experiences an adverse reaction is advised to report it to the FDA’s MedWatch Adverse Event Reporting Program. Questions regarding the recall can be made directly to Acella Pharmaceuticals by phone or email.

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From the Pharmaceutical Industry

Pfizer-BioNTech Vaccine Authorized for Use in Adolescents

On May 10, 2021, the FDA announced the expansion of Emergency Use Authorization (EUA) for Pfizer-BioNTech’s COVID-19 vaccine to include adolescents age 12-15. Prior to the expansion, the Pfizer-BioNTech vaccine was approved for use in individuals 16 and older. The EUA expansion was based on results from a Phase 3 trial, enrolling 2,260 patients, of which 1,129 received the vaccine instead of placebo, that demonstrated Pfizer’s COVID-19 vaccine was well tolerated and 100% effective in preventing disease in adolescents 12-15 with or without prior evidence of SARS-CoV-2 infection. A total of 18 cases of COVID-19 were seen in the unvaccinated group, while there were no COVID-19 cases in the vaccinated group. Data analysis also showed that the antibody response was even greater than that seen in participants 16-25 years old with a similar side effect profile. As a result of the EUA expansion for Pfizer/BioNTech’s vaccine, efforts will be made to vaccinate these new groups before the start of the next school year as part of the overall public health goal of reaching herd immunity. Pfizer-BioNTech have begun studies in children ages 6 months to 11 years earlier this month with hopes to further expand the EUA. Trials for the vaccines produced by Moderna and Johnson & Johnson for use in children and adolescents are currently ongoing.

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FDA Approvals

New FDA Drug Approvals

Novel Drug Approval: Jemperli® (dostarlimab-gxly)
Intravenous infusion approved for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer [4/22/21 – Orphan Drug - GLAXOSMITHKLINE]

Novel Drug Approval: Zynlonta™ (loncastuximab tesirine-lpyl)
Intravenous infusion approved for the treatment of adult patients with certain types of relapsed or refractory large B-cell lymphoma [4/23/21 – ADC Therapeutics SA]

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New Generics

New Generic Medications Entering the Marketplace

Absorica® (isotretinoin)
Indication: Severe nodular acne
Dosage Form/Strength: 10MG, 20MG, 25MG, 30MG, 35MG, and 40MG tablet
Average Wholesale Price (AWP): Generic = 10MG-40MG ($20.50-$28.25) | Brand = 10MG-40MG ($44.65-$48.04)