July 2023
PDR Drug Update
- Lead Story
- Latest FDA News
- FDA Recalls & Alerts
- Labeling Updates
Managing Menopause-Associated Vasomotor Symptoms Via New Nonhormonal Therapy
Well over 50 million women in the US are estimated to be in menopause. According to studies, approximately 80% of those individuals experience vasomotor symptoms of hot flashes and night sweats. Vasomotor symptoms are generally classified as either mild, with the feeling of heat but no sweating occurs; moderate, with the feeling of heat and sweating occurs, but activity can be continued; or severe, with the feeling of heat, sweating occurs, and activity cannot be continued. Significant sweating, flushed skin, disrupted sleep, anxiety, mood disturbance, and increased risk for cardiovascular disease can all be associated with hot flashes. The health impact extends well beyond general discomfort. Considerable reduction in the quality of life is a concern and burden for affected women.
When the usual levels of estrogen and progesterone begin to fluctuate, the body is entering perimenopause. Menopause is defined as when menstrual cycles have ceased for 12 months for a patient. As estrogen levels decrease as perimenopause/menopause occurs, the hormone's involvement in temperature regulation in the hypothalamus is impacted, allowing neurokinin 3 (NK3) receptors to become hyperactive. NK3 receptors are responsible for controlling kisspeptin/neurokinin/dynorphin neurons. When these neurons are unregulated, they continue to fire and cause hot flashes in the body. A new first-of-its-kind therapy that acts as an NK3 receptor antagonist has recently been approved. By blocking NK3, temperature control is regained, and vasomotor symptoms are reduced. The drug is known as Veozah (fezolinetant) and is indicated for treatment of moderate-to-severe vasomotor symptoms due to menopause. Veozah is a 45mg tablet taken once a day. The prescribing information includes a warning related to hepatic transaminase elevation, so prescribers must evaluate and monitor patients for hepatic function and injury.
As nonhormonal treatments like Veozah are continuing to be researched and developed, the North American Menopause Society (NAMS) has published a newly revised Nonhormone Therapy Position Statement for 2023 that addresses related prescribing strategies. Published in the June 2023 edition of the journal Menopause, the piece reinforces the value of hormone therapy as the most effective treatment for vasomotor symptoms. Still, it encourages the importance of healthcare providers being aware and highly informed regarding evidence-backed nonhormone treatment options. It is vital to be able to consult on the best therapy approach for patients who are unable to use hormonal therapy.
The annual meeting for NAMS will take place September 27-30, 2023, and will focus on "Midlife Women's Health in the Era of Precision Medicine." The meeting provides an opportunity to earn continuing education credits or pharmacotherapeutic credits. The guidance provided by authoritative resources such as NAMS can be helpful for healthcare providers. You can also stay informed about emergent drug information, including treatment options for symptoms of menopause, by updating or registering your profile to receive email alerts and other critical drug information updates from PDR. You can also stay current by using the official PDR app, mobilePDR, available for free from your favorite app stores.
FDA New Approvals
Abrysvo
The FDA has approved Abrysvo (respiratory syncytial virus vaccine) for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals aged 60 years and older. Abrysvo is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains. Learn more about Abrysvo
Columvi
The FDA has approved Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy. Learn more about Columvi
Elevidys
The FDA has approved Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus-based gene therapy for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Learn more about Elevidys
Lantidra
The FDA has approved Lantidra (donislecel), the first allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Learn more about Lantidra
Leqembi
The FDA has granted traditional approval for Leqembi (lecanemab-irmb) indicated to treat adult patients with Alzheimer’s disease. Leqembi is the first amyloid beta-directed antibody to receive traditional approval from the FDA for the treatment of Alzheimer’s disease. Learn more about Leqembi
Litfulo
The FDA has approved Litfulo (ritlecitinib), a once-daily oral treatment, for individuals aged 12 years and older with severe alopecia areata. Learn more about Litfulo
Lodoco
The FDA has approved Lodoco (colchicine) tablets as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. Learn more about Lodoco
Ngenla
The FDA has approved Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analogue indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone. Learn more about Ngenla
Pemrydi RTU
The FDA has approved Pemrydi RTU (pemetrexed) injection, a ready-to-use (RTU) presentation of pemetrexed. This product is the first and only RTU presentation of pemetrexed for injection and does not require reconstitution, dilution, or refrigeration. Learn more about Pemrydi RTU
Roctavian
The FDA has approved Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity <1 IU/dL) without antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test. The one-time, single-dose infusion is the first approved gene therapy for severe hemophilia A in the US. Learn more about Roctavian
Rystiggo
The FDA has approved Rystiggo (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. Learn more about Rystiggo
Suflave
The FDA has approved Suflave (magnesium sulfate/polyethylene glycol/potassium chloride/sodium chloride/sodium sulfate) for oral solution, for colonoscopy preparation in adults. Learn more about Suflave
Vevye
The FDA has approved Vevye (cyclosporine) ophthalmic solution 0.1% for the treatment of the signs and symptoms of dry eye disease. Vevye is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease. Learn more about Vevye
Vyvgart Hytrulo
The FDA has approved Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase-qvfc) injection for subcutaneous use for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. Learn more about Vyvgart Hytrulo
FDA First-Time Generic Approvals
Tiotropium Bromide Inhalation Powder
The FDA has approved tiotropium bromide inhalation powder, 18mcg/capsule, a generic equivalent of Spiriva HandiHaler (tiotropium bromide) inhalation powder, 18mcg/capsule. This is the first generic approval for Spiriva HandiHaler in the US. Learn more about tiotropium bromide inhalation powder
FDA New Indications
Bylvay
The FDA has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients aged 12 months and older with Alagille syndrome. Learn more about Bylvay
Jardiance
The FDA has approved Jardiance (empagliflozin) 10mg and 25mg tablets to lower blood sugar along with diet and exercise in children aged 10 years and older with type 2 diabetes. Learn more about Jardiance
Liletta
The FDA has approved a supplemental new drug application for Liletta (levonorgestrel-releasing intrauterine system) 52mg for treatment of heavy menstrual bleeding for up to five years in patients who choose intrauterine contraception as their method of contraception. Learn more about Liletta
Linzess
The FDA has approved Linzess (linaclotide) as a once-daily treatment for pediatric patients aged 6-17 years with functional constipation. Linzess is the first and only FDA-approved prescription therapy for functional constipation in this patient population. Learn more about Linzess
Prevymis
The FDA has approved a new indication for Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (donor CMV-seropositive/recipient CMV-seronegative [D+/R-]) following a priority review. Learn more about Prevymis
Synjardy
The FDA has approved Synjardy (empagliflozin/metformin HCl) as an adjunct to diet and exercise to improve blood sugar control in children aged 10 years and older with type 2 diabetes mellitus. Learn more about Synjardy
FDA New Combinations
Lynparza + Abiraterone
The FDA has approved Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer. Learn more about Lynparza + abiraterone
Talzenna + Xtandi
The FDA has approved Talzenna (talazoparib), an oral poly ADP-ribose polymerase inhibitor, in combination with Xtandi (enzalutamide), for the treatment of adult patients with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer. Learn more about Talzenna + Xtandi
FDA Recalls
Cipla Albuterol Sulfate
Cipla US is voluntarily recalling six batches of albuterol sulfate inhalation aerosol, 90mcg (200 metered inhalation) manufactured in November 2021, to the consumer level. Learn more about the Cipla albuterol sulfate recall
Major Pharmaceutical and Rugby Laboratories Dronabinol and Ziprasidone HCl
Major Pharmaceutical and Rugby Laboratories are initiating a voluntary recall of a single lot of dronabinol capsules, USP, 2.5mg and ziprasidone hydrochloride capsules, 20mg, to the consumer level. A customer complaint indicated that some unit dose cartons labeled as ziprasidone hydrochloride capsules, 20mg were found to contain blister packages labeled as and containing dronabinol capsules, USP, 2.5mg for Lot T04769. Accordingly, the recall is for Lot T04769, dronabinol capsules, USP, 2.5mg, which may be in outer cartons that read dronabinol capsules, USP, 2.5mg OR ziprasidone hydrochloride capsules, 20mg. Learn more about the Major Pharmaceutical and Rugby Laboratories dronabinol and ziprasidone HCl recall
Labeling Updates
- Key
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Boxed Warning
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Other Warnings*
*Warnings and Precautions; Adverse Reactions; Drug Interactions; and Contraindications
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Updates to Indications/Dosage
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Other Updates†
†Other labeling changes; added to PDR database
No Oriahnn boxed warning | No Oriahnn Other Warnings | No Oriahnn Indications/Dosage Updates | Oriahnn (elagolix/estradiol/norethisterone) | |
No Orilissa boxed warning | No Orilissa Indications/Dosage Updates | Orilissa (elagolix) |
No Rinvoq boxed warning | Rinvoq (upadacitinib) | |||
No Skyrizi boxed warning | No Skyrizi Other Updates | Skyrizi (risankizumab-rzaa) |