FDA Approves Treatment for Acute Myeloid Leukemia
On September 1, 2020, the U.S. Food and Drug Administration (FDA) approved
Onureg® (azacitidine) oral tablets for continued treatment of acute myeloid leukemia (AML).
Onureg® is the only FDA-approved drug indicated for adult patients who achieved
complete remission (CR)
or complete remission with blood cell counts that have not yet returned to normal levels following intensive
but are unable to complete intensive curative therapy. AML is a type of cancer that typically originates in
early forms of white blood cells in the bone marrow and can quickly spread to the blood. Onureg® works by altering the DNA and
promoting death of the cancerous white blood cells, while preserving the function and growth of normal cells. The safety and efficacy
of the medication were evaluated in the QUAZAR trial
which included 472 patients and spanned over 6 years. Results have shown
that patients receiving Onureg® had a significantly higher median overall survival (OS) compared to patients receiving placebo (24.7
months vs. 14.8 months, respectively). This benefit was shown in patients that yielded both CR and CRi. Onureg® was awarded Orphan
Drug and Priority Review designations. Onureg® provides an additional treatment option for more than 64,000 Americans estimated
to be living with AML.
RLC Labs Inc. Issues Voluntary Nationwide Recall of Thyroid Medications
On September 3, 2020, RLC Labs Inc. announced a voluntary recall
at the consumer level of 483 lots of Nature-Throid® and WP
Thyroid® in all strengths and all counts of product within current expiry. The recall occurred after the FDA discovered samples from
six lots of medication with a lower potency than indicated on the label, containing as low as 87% of labeled active ingredients. These
medications are used to treat underactive thyroid, a common condition often known as hypothyroidism. Patients receiving sub-potent
therapy with recalled lots may experience symptoms of hypothyroidism, including fatigue, sensitivity to cold, constipation, hair loss,
slow heart rate, depression, puffy face and weight gain. Pregnant women with undertreated hypothyroidism, elderly patients, and
patients with underlying cardiac disease may be at greater risk for complications associated with sub-potent thyroid treatment. RLC
Labs Inc. is notifying wholesalers to discontinue distribution of the product, and patients currently taking Nature-Throid® and WP
Thyroid® are being asked to contact their health care provider and not discontinue therapy on their own.
FDA Authorizes Antibody Test in Point-of-Care Settings
The FDA announced
an emergency use authorization for the first serology (antibody) test for COVID-19 that can be used in pointof-
care (POC) settings such as primary care offices, hospitals and emergency rooms. The Assure COVID-19 IgG/IgM Rapid Test
Device is available by prescription only, and detects certain antibodies produced by the human body’s immune system in response to
COVID-19 infection. It can detect these antibodies in venous whole blood, serum, plasma and whole blood acquired by a fingerstick.
The acquisition of a blood sample by fingerstick and ability to be tested in POC settings makes this test unique. Previous diagnostics
techniques required use of a central lab for testing, which required additional resources and time to transport samples and run tests.
The FDA stated that authorizing serology tests in POC settings “will enable more timely and convenient results for individuals who
want to understand if they have previously been infected with the virus that causes COVID-19.” The FDA also emphasized that
antibody tests do not test for active infection, and that patients should not interpret the results of a serology test as confirmed
immunity from the virus, as it is unknown how long the antibodies remain in the human body, and whether or not the presence of
these antibodies dictates protective immunity. The FDA continues to work on the expansion of COVID-19 testing and reminds the
public to continue social distancing and wearing masks in order to protect themselves and others.
New Generics Entering the Marketplace
Indication: HIV-1 Infection
Dosage Form/Strength: 200 MG oral capsules
Average Wholesale Price (AWP): Generic = $579 | Brand = $819