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Pulse Newsletter

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

Volume 3 | Issue 1
January 1, 2021

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

Clinical Update

FDA Grants Emergency Use Authorization to First COVID Vaccines

On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued emergency use authorization (EUA) for Pfizer-BioNTech’s COVID-19 vaccine for use in individuals 16 years and older. The EUA was issued after the FDA determined that the vaccine met outlined safety and efficacy thresholds. Although an EUA is an accelerated, temporary approval, the FDA has continued to hold trial vaccines to rigorous standards, requiring proven efficacy of at least 50% as well as two months of safety data. Based on clinical trials, the Pfizer-BioNTech vaccine was found to be 95% effective at preventing COVID-19 illness in individuals with no previous infection, far exceeding the 50% threshold set by the FDA. The first few million doses were shipped to sites across the country in special coolers packed with 50 pounds of dry ice. Once delivered, the vaccines must be stored in ultra-low temperature freezers in order to prevent loss of efficacy. Another shipment of doses will then follow to complete the 2-dose sequence of the vaccine. . Those first to receive the vaccine will include health care workers and nursing home residents. Younger individuals and others who are not considered to be at high risk may not be able to receive the vaccine until early summer. Vaccination rates will increase in 2021 as production ramps up and additional vaccines receive EUA or even FDA approval. The FDA has been working rigorously to help combat the pandemic and has since issued another COVID-19 vaccine EUA to Moderna for use in individuals 18 years and older. The challenges concerning storage and handling of the Pfizer-BioNTech vaccine are somewhat alleviated with the Moderna vaccine, which does not require as extreme of temperatures for shipping and storage.

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Safety First

Torrent Pharmaceuticals Voluntarily Recalls Anagrelide Capsules

On December 9, 2020, the FDA announced Torrent Pharmaceuticals’ voluntary recall of anagrelide capsules. Anagrelide is a treatment for thrombocythemia, a blood disorder which occurs when the body produces too many platelet cells. The recall was issued after a routine quality test showed dissolution test failure. Dissolution, the process in which a dosage form — such as a capsule — forms a solution, is used as a prediction of how a drug is released and becomes available in the body. Inadequate dissolution is correlated with subtherapeutic levels of medication, and for patients with thrombocythemia, this may result in an increased risk of clotting, leading to heart attack or stroke. Patients should contact their pharmacist or physician to discuss starting an alternative treatment prior to returning the medication, as abruptly stopping anagrelide may present a greater risk. Torrent Pharmaceuticals is advising immediate discontinuation of distribution of the specific lot being recalled. Adverse reactions or quality concerns should be reported to the FDA’s MedWatch Adverse Event Reporting Program. Medical questions regarding the recall may be addressed directly with Torrent Pharmaceuticals. To date, no complications associated with the recall have been reported.

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From the Industry

FDA Grants Sotorasib Breakthrough Therapy Designation for Treatment of Lung Cancer

On December 8, 2020, Amgen announced that the FDA granted sotorasib Breakthrough Therap designation for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRASG12C mutation, following at least one prior systemic therapy. The KRAS gene, which develops a protein known to regulate cell growth, is one of the most frequently mutated genes associated with cancer and solid tumor development. Additionally, KRASG12C is the most common mutation associated with NSCLC, thought to occur in 13% of NSCLC patients. Despite the prevalence of KRAS mutations in cancer patients, scientists have had a difficult time targeting the protein throughout four decades of research. Sotorasib is a targeted therapy that is able to inactivate KRASG12C by irreversibly binding to the surface of the protein. Locking the protein in its inactivated form results in prolonged inhibition of signals promoting cancer growth. The Breakthrough Therapy designation comes after a phase 2 clinical study, CodeBreaK 100, which enrolled 126 patients with NSCLC and tumors positive for the KRASG12C mutation who had progressing cancer despite prior chemotherapy and/or immunotherapy. The study showed that patients treated with sotorasib achieved lasting anticancer activity and a positive benefit-risk profile, which indicates a significant step forward for cancer patients with KRAS mutation. Additional trials involving patients with various other types of cancer are taking place as part of the CodeBreaK clinical development program.

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FDA Approvals

Recent FDA Approvals

New Dosage Form: Hetlioz LQ™ (tasimelteon)
Oral suspension indicated in the treatment of nighttime sleep disturbances in pediatric patients 3-15 years old with Smith-Magenis Syndrome (SMS) [12/1/20 – Priority ReviewOrphan Drug – VANDA PHARMS INC]

Novel Drug Approval: Orladeyo™ (berotralstat hydrochloride)
Oral capsule indicated for prevention of attacks of hereditary angioedema (HAE) in patients 12 years and older [12/3/20 – Orphan Drug – BIOCRYST]

Novel Drug Approval: Klisyri®(tirbanibulin)
Topical ointment indicated in the treatment of actinic keratosis of the face or scalp [12/14/20 – ATHENEX INC]

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New Generics

New Generics Entering the Marketplace

*As of this issue, there were no new generics entering the marketplace. However, there are several projected launches we are monitoring, including:

Amitiza® (lubiprostone)
Indication: Treatment of chronic idiopathic and opioid-induced constipation in adults and irritable bowel syndrome with constipation in women 18 years and older.
Dosage Form/Strength: 8 and 24 MCG Oral Capsules
Projected Launch: 1/1/2021

Enjuvia® (synthetic conjugated estrogens)
Indication: Menopausal symptoms in adult women
Dosage Form/Strength: 0.3, 0.45, 0.625, 0.9, 1.25 MG Tablets
Projected Launch: 3/8/2021