Pulse Newsletter
Your source for the latest industry trends and drug information news.
Volume 3 | Issue 15
August 1, 2021
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate
Clinical Pharmacy Update
FDA Approves New Medication for Patients with Chronic Kidney Disease and Type 2 Diabetes
On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) for adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. Kerendia® aims to reduce the risk of serious kidney and heart complications associated with these two chronic conditions including decline in kidney function, kidney failure, death due to cardiovascular disease, non-fatal heart attacks and hospitalization due to heart failure. CKD is a condition characterized by kidney damage and a gradual loss of kidney function over time, which has the potential to progress to kidney failure. When kidney function decreases, the kidneys
cannot filter blood the way they should. Wastes can accumulate in the blood, causing complications such as increased blood pressure, anemia (low red blood cell count), and electrolyte imbalance. Kerendia® was shown to improve kidney and heart-related outcomes in a study of 5,674 patients who were randomly assigned to be treated with either Kerendia® or placebo. Results showed that only 17.8% of patients in the Kerendia® group progressed to one of the three serious kidney complications (at least a 40% reduction in kidney function, progression to kidney failure, or death caused by kidney failure) compared to 21.1% of those in the placebo group. Results also showed that only 13% of the Kerendia® group experienced one of the four serious heart complications (death due to cardiovascular disease, non-fatal heart attack, non-fatal stroke, or hospitalization due to heart failure) compared to 14.8% of the placebo group. Side effects of Kerendia® include high levels of potassium in the blood, low blood pressure, and low levels of sodium in the blood. With its approval, Kerendia® provides an additional treatment option for people living with type 2 diabetes and CKD in the United States.
Drug Safety
Teva Recalls Topotecan Injection Due to Presence of Particulate Matter
On June 30, 2021, Teva initiated a voluntary recall of Topotecan Injection 4 mg/4 mL vials in the United States. Topotecan Injection is indicated for the treatment of patients with cervical cancer, metastatic ovarian cancer, or small cell lung cancer (SCLC) following trial and failure of previous chemotherapy. The recall was initiated following a complaint received from a pharmacy after they noticed a glass particle, grey silicone, and cotton fiber in one of the vials. Had the particulates been infused, there is potential for them to travel to various organs and block blood vessels in the heart, lungs or brain which can cause serious complications such as stroke, or even
death. With this in mind, Teva assessed the likelihood that patients would be exposed to the recalled product and determined it to be unlikely and had not received any complaints or reports of illness or injury at the time of the recall. Out of caution, Teva notified its customers that the lot has been recalled, and provided instructions for returning recalled products within a recall letter. Adverse reactions or quality problems related to the recall should be made to the FDA’s MedWatch Adverse Event Reporting Program.
From the Pharmaceutical Industry
Pfizer Seeks FDA Authorization for COVID-19 Booster
On July 8, 2021, Pfizer-BioNTech, the makers of the first COVID-19 vaccine that was granted emergency use authorization by the FDA in the United States, announced that they are planning to seek approval for a third dose of their mRNA based COVID-19 vaccine. The companies are looking for approval of a booster dose to provide additional protection for individuals who have completed the two-dose regimen of their vaccine. Pfizer-BioNTech reported that initial data from an ongoing clinical trial show that a third shot, administered six months after the second, can raise the blood proteins that protect against infection to levels 5-10 times than those seen after the second dose, which may provide additional protection against infection with COVID-19. Data from the trial is expected to be submitted to the FDA in the coming weeks. Pfizer has already demonstrated that completion of their current 2-dose regimen provides adequate protection against COVID-19 strains, such as the Delta variant. Pfizer-BioNTech are also in development of an updated version of the COVID-19 vaccine, which will target the Delta variant directly. In response to Pfizer-BioNTech’s announcement, the CDC and the FDA released a joint statement saying that “Americans who have been fully vaccinated do not need a booster shot at this time.” While current studies suggest that mRNA vaccines provide long-term protection against severe disease, there is evidence that protection against symptomatic disease may decline six months after vaccination. A booster shot may help provide the highest possible level of protection against COVID-19, and the FDA and CDC will continue to evaluate new clinical trial data as it becomes available to determine if a booster shot is needed in the future.
FDA Approvals
New FDA Drug Approvals
Novel Drug Approval: Kerendia® (finerenone)
Oral tablets approved to reduce the risk of declining kidney function, cardiovascular death, non-fatal heart attack and hospitalization due to heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes [07/09/21 – Fast Track; Priority Review – BAYER HEALTHCARE]
New Generics
New Generic Medications 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:
Sutent® (sunitinib maleate)
Indication: Cancer of the gastrointestinal tract, kidneys and pancreas
Dosage Form/Strength: 12.5, 25, 37.5 and 50 mg oral capsules
Projected Launch: August 16, 2021
Bystolic® (nebivolol hydrochloride)
Indication: Hypertension (high blood pressure)
Dosage Form/Strength: 2.5, 5, 10 and 20 mg oral tablets
Projected Launch: September 17, 2021