Monthly News Roundup - July 2023
Medically reviewed by Drugs.com.
FDA Clears Opill, the First Over-the-Counter (OTC) Oral Birth Control Pill
History in women’s health was made in July when the FDA cleared Opill (norgestrel 0.075 mg), the first over-the-counter (OTC) oral birth control option available in the US. Opill is expected to be available for purchase on shelves by early 2024.
- Opill is a progestin-only pill (POP), often referred to as a “mini-pill”, taken every day at the same time with no breaks between packs. It is approved for use in all ages, and does not require a prescription or doctor’s visit.
- The OTC version of Opill is identical to the prescription POP product which is 91% effective at preventing pregnancy with typical (real-world) use. It does not contain estrogen.
- When available, Opill will be the most effective form of any contraceptive available without a prescription. Opill is NOT for use as an emergency contraceptive and will not prevent pregnancy after unprotected sex.
- The cost is not yet known, but the manufacturer, Perrigo Company, has committed to making the contraceptive accessible and affordable. It remains to be seen if insurance will cover the cost of Opill as an over-the-counter (OTC) product in the U.S.
Nonprescription RiVive Nasal Spray Approved to Treat Opioid Overdose
Since 2017, more than 290,000 people across the U.S. have died of an opioid overdose At the end of July, the FDA approved RiVive (naloxone HCl nasal spray 3 mg) as an over-the-counter (OTC), nonprescription option for the emergency treatment of opioid overdose.
- Naloxone is a safe and effective FDA approved opioid antagonist that has been used for decades to reverse opioid overdoses, including prescription pain medicines and street drugs like heroin.
- Naloxone is used for adults and children for known or suspected opioid overdose if there are signs of slowed breathing, severe sleepiness, or the person is not able to respond (loss of consciousness).
- Each RiVive nasal spray device contains one 3 mg dose of naloxone and comes in a twin pack. After the first dose is given, immediately call for emergency medical help (call 911 in the US). It is safe to keep administering RiVive every 2 to 3 minutes until the person wakes up.
- RiVive is manufactured by Harm Reduction Therapeutics (HRT), a nonprofit pharmaceutical company. This lower-cost option is expected to be available to harm reduction organizations and state governments in early 2024, with about 10% of the annual product available for free.
- Narcan nasal spray was also FDA-approved in March 2023 as an OTC option and will be available soon on shelves and online.
Beyfortus Vaccine Wins Approval for RSV Prevention in Small Children
Respiratory syncytial virus (RSV) is the leading cause of hospitalization for infants under the age of one in the US. In July, the FDA approved AstraZeneca and Sanofi’s Beyfortus (nirsevimab-alip) to prevent RSV lower respiratory tract disease in newborns and babies under 1 year of age born during or entering their first RSV season, AND children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season.
- RSV is a highly contagious virus that can lead to serious respiratory tract illness. RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing. RSV typically occurs in the fall through spring seasons in the U.S.
- Beyfortus is an antibody which helps to prevent RSV disease for 5 months. Dosages are weight-based and given as an intramuscular (IM) injection.
- The primary endpoint of the placebo-controlled MELODY Phase III trial was met, reducing the incidence of medically attended lower respiratory tract disease due to RSV, such as bronchiolitis or pneumonia, by 74.9%, with hospitalization (a secondary endpoint) reduced by 60.2%.
- In studies, the most common side effects were rash (0.9%) and injection site reactions (0.3%). Safe and effective use in children older than 24 months of age is not established
- Beyfortus will be available in the U.S. ahead of the upcoming 2023-2024 RSV season. Recently approved RSV vaccines for adults 60 years of age and older include Arexvy and Abrysvo.
FDA Clears Vanflyta for FLT3-ITD Positive Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is cancer that starts inside bone marrow, the soft tissue inside bones that helps form blood cells. About 20,300 new cases of AML will be diagnosed in the U.S. in 2023. This past month, the FDA approved Daiichi Sankyo’s Vanflyta (quizartinib), an oral FMS-like tyrosine kinase-3-internal tandem duplication (FLT3-ITD) inhibitor for the treatment of patients with FLT3-ITD positive acute myeloid leukemia (AML).
- Vanflyta is used in combination with standard chemotherapies cytarabine and anthracycline, and used alone as maintenance treatment following consolidation chemotherapy in adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.
- FDA approval for Vanflyta was based on the results from the QuANTUM-First trial which demonstrated that Vanflyta used per protocol resulted in a statistically significant 22% reduction in the risk of death compared to standard chemotherapy alone. The median duration of complete remission (CR) was 38.6 months for patients receiving Vanflyta compared to 12.4 months for those receiving placebo plus standard chemotherapy alone.
- Vanflyta tablets are taken orally once daily with or without food, at approximately the same time each day. It is available only through a restricted program called the Vanflyta Risk Evaluation and Mitigation Strategy (Vanflyta REMS).
- The label carries a Boxed Warning for QT interval prolongation and torsades de pointes (abnormal heart rhythms), and cardiac arrest (sudden loss of all heart activity due to an irregular heart rhythm).
- Common side effects include diarrhea, mucositis (inflamed mouth, mouth sores), nausea, lowered calcium levels, abdominal (stomach area) pain, sepsis (serious infection reaction), neutropenia (low white blood cells), headache, vomiting, and upper respiratory tract infection.
Ycanth OK’d to Treat Molluscum Contagiosum in Patients 2 Years and Older
Molluscum contagiosum is a contagious viral skin condition that results in round, firm, painless bumps. It primarily affects children and can spread from person-to-person or from objects. In response, the FDA has approved Ycanth (cantharidin 0.7% solution) from Verrica Pharmaceuticals, a topical terpenoid for the treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.
- Cantharidin is a vesicant secreted from certain beetles and has been in use since the 1950’s to treat warts and Molluscum. It’s thought to work by activation of serine protease enzymes, leading to acantholysis (loss of structure between epidermal cells) and intraepidermal blisters, which typically heal without scarring.
- Ycanth is only to be administered by a trained healthcare professional via a single-use applicator and is not for home use. Life threatening or fatal toxicities can occur if Ycanth is administered orally. Ycanth is applied as a single application directly to each lesion and removed with soap and water after 24 hours. Treatments can be reapplied every 3 weeks if needed.
- It is not for use in the mouth, nose, genital areas, or eyes. The inactive ingredient denatonium benzoate is a bittering agent to discourage licking or accidental swallowing. Ycanth is flammable, even after it dries, and patients should avoid fire, flame, or smoking near the lesions until Ycanth is removed. Also avoid inhaling vapors.
- In the Phase 3, CAMP-1 and CAMP-2 studies, Ycanth led to a statistically significant and complete clearance of molluscum lesions in 46% and 54% of participants, compared to 18% and 13% receiving the vehicle, respectively.
- In studies, mild to moderate local skin reactions were expected and occurred in 97% of people at the application site, including vesiculation (blistering), pain, itching, scabs, redness, discoloration, dryness, swelling, and erosion (skin breakdown). The discontinuation rate due to side effects was 2.3% in the Ycanth group and 0.5% in those receiving the vehicle.
- Ycanth is expected to be commercially available by September 2023.
Xdemvy Ophthalmic Solution Cleared as First Treatment of Demodex Blepharitis
Demodex blepharitis occurs in the eyelash follicles and is caused by overpopulation of Demodex mites, the most common ectoparasite that lives on human skin. It can cause eyelid inflammation, redness and irritation. In July, the FDA cleared Tarsus Pharmaceuticals’ Xdemvy (lotilaner 0.25% ophthalmic solution), an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis in adults.
- Xdemvy is an isoxazoline ectoparasiticide that works by selectively inhibiting parasite-specific gamma-aminobutyric acid (GABA)-gated chloride channels leading to mite paralysis and death.
- In the Saturn-1 and Saturn-2 randomized, vehicle-controlled studies in 833 patients, statistically significant mite eradication (defined as mite density of 0 mites / lash) occurred in 68% and 50% of participants receiving Xdemvy, compared to 17% and 14% of those using the vehicle, respectively, at day 43 of treatment. Erythema (eyelid redness) was also significantly improved with Xdemvy.
- To use Xdemvy, instill one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks. Remove contact lenses before putting Xdemvy into your eye (may reinsert your lenses 15 minutes after use). Xdemvy contains potassium sorbate, which may discolor soft contact lenses.
- Common adverse reactions (10%) include stinging and burning in the eye after drop instillation.
Balfaxar Approved for Warfarin Reversal in Urgent Surgery, Procedures
In July, the FDA cleared Balfaxar (prothrombin complex concentrate, human-lans) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (such as warfarin) in adults with need for an urgent surgery or an invasive procedure. Patients on warfarin or vitamin K antagonists have an increased risk of bleeding in these situations.
- Balfaxar is a non-activated four factor prothrombin complex concentrate (4F-PCC). It contains the vitamin K-dependent factors Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S. Balfaxar works to reverse the effects of blood-thinning medicines like warfarin by restoring blood clotting factors needed for blood to clot.
- Approval was supported by the LEX-209 clinical trial, a head-to-head trial with Kcentra (used as a control 4F-PCC). Balfaxar met the primary endpoint of hemostatic efficacy and was determined to be non-inferior to Kcentra, with Balfaxar demonstrating effective hemostasis in 94.6% of patients versus 93.5% of patients for Kcentra. Safety was similar as well.
- Balfaxar is given as an intravenous (IV) infusion at a dose based on the patient’s baseline INR value and body weight.
- The label carries a Box Warning for thromboembolic (blood clot) complications. Common side effects include procedural pain, wound complications, asthenia (weakness), anemia (low red blood cells), dysuria (painful urination), procedural vomiting and catheter site related reaction.
- Balfaxar is from Octapharma USA.
Gilead’s Veklury OK’d for COVID-19 Treatment in Severe Kidney Impairment, Dialysis
Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19. This month, the FDA cleared Veklury use in COVID-19 patients with severe renal (kidney) impairment, including those on dialysis. No dosage adjustments are needed for any degree of renal impairment, including dialysis.
- Veklury is approved for the treatment of COVID-19 in adults and pediatric patients (28 days and older and weighing at least 3 kg) who are either hospitalized, or not hospitalized with mild-to-moderate disease and are at high risk for progression to severe COVID-19, including hospitalization or death.
- The updated prescribing information for Veklury does not require dose adjustments for renally-impaired patients and removes the requirement for eGFR testing before or during treatment with Veklury.
- This approval was based on results from a Phase 1 study (GS-US-540-9015), as well as the Phase 3 REDPINE trial that demonstrated the pharmacokinetics and safety profile of Veklury in this patient population.
- The most common side effects (at least 5%) were nausea and elevated liver enzymes (ALT, AST).
Leqvio Population Expanded to Include Primary Prevention in Adults with High LDL Cholesterol
In July, Novartis announced that Leqvio (inclisiran), added to diet and statin therapy, can now be used earlier to lower LDL (“bad”) cholesterol in patients who have not had a cardiovascular event (heart attack, stroke), but are at an increased risk of heart disease. This patient population includes those who have comorbidities such as hypertension (high blood pressure) and diabetes.
- Leqvio is a small interfering RNA (siRNA) therapy with a unique mechanism of action. It works by preventing the formation of a protein (PCSK9) that keeps blood cholesterol levels high.
- Leqvio was first approved by the FDA in Dec. 2021. It is now labeled as an adjunct to diet and statin therapy for adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C). HeFH is an inherited condition that causes high levels of LDL-C
- Leqvio 284 mg is given by a healthcare provider as a subcutaneous (under the skin) injection initially (the first dose), then at 3 months, and then every 6 months thereafter, making it a twice yearly maintenance dose. It is injected into the abdomen, upper arm, or thigh.
- Common side effects (≥ 3%) include injection site reaction (including pain, redness, and rash), arthralgia (joint pain), and bronchitis (chest cold). Adverse reactions led to discontinuation of treatment in 2.5% of patients treated with Leqvio and 1.9% of patients treated with placebo.
Posted July 2023
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