Monthly News Roundup - December 2020
Moderna and Pfizer’s COVID-19 Vaccines Roll Out in Early Phase
In December, the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. In studies, the vaccines were found to be 94% to 95% effective in preventing COVID-19 disease.
- How do they work? The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. The partial piece of the spike protein cannot cause COVID-19 disease.
- The dose for the Pfizer-BioNTech vaccine (for patients 16 years of age and older) is a series of two intramuscular (IM) injections in the upper arm given 3 weeks (21 days) apart. The Moderna vaccine (for patients 18 years of age and older) is also a 2-dose series, but separated by 4 weeks (28 days). After administration, you’ll need to stay where you received the vaccine for 15 to 30 minutes for observation.
- Current guidelines to prevent the spread of COVID-19 should be followed after vaccination: wear a mask, maintain 6 feet of distance, avoid crowds and wash your hands frequently. COVID-19 is still spreading rapidly throughout the U.S. The duration of protection from the vaccines are not known yet.
- Commonly reported side effects include injection site pain or swelling and flu-like symptoms such as fever, chills, tiredness, muscle and joint pain, and headache. These side effects subside in a few days in most patients. In some cases, side effects may be worse after the second dose than the first dose.
- Severe allergic reactions (anaphylactic reactions) are rare but have been reported. These reactions can be treated, and most patients with allergies can still get the vaccine. It is recommended you do not use the vaccine if you have had a severe allergic reaction to any of the ingredients in the vaccine you receive, or to a previous dose of the vaccine. See more from the CDC about severe allergic reactions with the COVID-19 vaccine.
Orgovyx: The First Oral GnRH Antagonist for Advanced Prostate Cancer
Prostate cancer is the second leading cause of death due to cancer in men in the U.S. In mid-December, the FDA approved Orgovyx (relugolix), the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer.
- Orgovyx blocks the GnRH receptor and reduces production of testosterone, a hormone known to stimulate the growth of prostate cancer.
- In the Phase 3 HERO study, treatment with Orgovyx led to sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% of men, compared with 88.8% of men receiving leuprolide acetate injections, the current standard of care.
- Common side effects include hot flush, elevated glucose, triglycerides and ALT, fatigue, muscle pain, decreased hemoglobin, constipation, and diarrhea.
- Orgovyx, from Myovant Sciences, is expected to be available in January 2021.
Margenza Cleared to Treat Metastatic HER2-Positive Breast Cancer
The FDA has approved Margenza (margetuximab-cmkb), in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
- Margenza, from MacroGenics, is classified as a HER2/neu receptor antagonist. It is given as an intravenous (IV) infusion over 120 minutes for the initial dose, then over at least 30 minutes every 3 weeks for subsequent doses.
- Based on data from 536 patients in the Phase 3 SOPHIA study, Margenza plus chemotherapy demonstrated a significant 24% reduction in disease progression or death when compared with trastuzumab plus chemotherapy (median PFS 5.8 vs 4.9 months; ORR 22% vs. 16%).
- Margenza carries a Boxed Warning for left ventricular dysfunction and embryo-fetal toxicity. Common side effects include fatigue / weakness (57%), nausea (33%), diarrhea (25%), and vomiting (21%).
FDA Approves First-In-Class Topical Klisyri to Treat Actinic Keratosis
Actinic keratosis (AK) is a common precancerous skin lesion. Roughly 10% to 15% of AK lesions will develop into skin cancers if left untreated. In response, the FDA has approved Klisyri (tirbanibulin) ointment 1% for the topical treatment of AK on the face or scalp in adults.
- Klisyri is classified as a first-in-class dual Src Kinase and tubulin polymerization inhibitor (microtubule inhibitor). Klisyri is applied once daily for 5 consecutive days using one single-dose packet per application.
- In Phase 3 studies, Klisyri demonstrated complete clearance of actinic keratosis lesions at day 57 in significantly more patients (44% to 54%) when compared to the vehicle (5% to 13%).
Common side effects were local skin reactions (primarily mild to moderate in degree), application site itching (9%) and application site pain (10%).
Klisyri, from Athenex, is expected to launch in the first quarter of 2021.
Gemtesa Tablets OK’d for Patients with Overactive Bladder (OAB)
More than 30 million Americans suffer from symptoms of overactive bladder (OAB). Gemtesa (vibegron) is now FDA-approved in adults for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
- Gemtesa is classified as a beta-3 adrenergic agonist. It works by relaxing the detrusor bladder muscle so that the bladder can hold more urine and reduce symptoms of OAB. It is taken as one 75 mg tablet once daily.
- Approval was based on studies in over 4,000 OAB patients. Gemtesa resulted in statistically significant reductions in daily urge urinary incontinence, number of urinations, and urgency episodes when compared to placebo in the Phase 3 EMPOWUR study.
- Common side effects were headache (4%), nasopharyngitis (2.8%), diarrhea (2.2%), nausea (2.2%), and upper respiratory tract infection (2%).
Gemtesa, from Urovant Sciences, is expected to launch late in the first quarter of 2021.
Orladeyo: First Oral, Once-Daily Therapy to Prevent Hereditary Angioedema Attacks
Hereditary angioedema (HAE) is a rare but serious genetic immune system disorder. It can cause life-threatening swelling, particularly of the face and airways, among other symptoms. This month the FDA approved oral Orladeyo (berotralstat) to prevent attacks of HAE in patients 12 years and older. Orladeyo should not be used for the treatment of acute HAE attacks.
- Orladeyo decreases the activity of plasma kallikrein. It is taken as one 150 mg capsule once daily with food. Additional doses or dosages higher than 150 mg once daily are not recommended due to the potential for QT prolongation.
- In the Phase 3 APeX-2 trial, Orladeyo significantly reduced attacks at 24 weeks and sustained reduction through 48 weeks. HAE attacks declined from a mean of 2.9 attacks per month to 1 attack per month after 48 weeks of treatment.
- Side effects in patients receiving Orladeyo 150 mg were abdominal pain (23%), vomiting (15%), diarrhea (15%), back pain (10%), and gastroesophageal reflux disease (5%).
- Orladeyo, from BioCryst Pharmaceuticals, is available now for prescribing.
Posted: December 2020
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.