PDR Drug Update - September 2024

Improving Quality of Life for Those with Hyperhidrosis

Individuals who live with hyperhidrosis experience varying levels of stress directly stemming from the condition. Certain patients may not even investigate solutions with a healthcare provider due to social conditioning to feel uncomfortable about their symptoms. Anxiety and depression are potential risks for those who are unable to find effective disease management. Continued research and development of new treatments for patients with hyperhidrosis are expanding the array of options that can help improve their quality of life.

The human body has eccrine glands in most of the areas of the skin. They are responsible for the sweat production that regulates body temperature as it travels to the skin’s surface to evaporate. When the cholinergic receptors on the glands are overstimulated, the resulting excessive sweating is referred to as hyperhidrosis. The condition has two classifications: primary and secondary. If the sweating is not caused by another disease, it is categorized as primary hyperhidrosis. The sweating typically affects the locations in the body with a concentration of eccrine glands, including the axillae, palms, soles, and face.

Pharmaceutical management of hyperhidrosis begins with the use of topical aluminum chloride. The location of the body where hyperhidrosis is problematic will influence what other therapies are used to control symptoms. If hyperhidrosis affects the head and face, a prescription cream containing glycopyrrolate may be chosen. Prescription wipes soaked in glycopyrronium tosylate are another topical application that can help with symptoms of hands, feet, and axillae. Injections using botulinum toxin are used in severe situations to help block the nerves that stimulate sweating. Other medication treatments include oral systemics, such as diltiazem, propranolol, clonidine, and anticholinergics. A recent FDA approval for a new topical anticholinergic brings one more option for prescribers aiming to alleviate patient symptoms.

The new approval is Sofdra (sofpironium) topical gel, 12.45%, for the treatment of primary axillary hyperhidrosis in adults and children aged 9 years or older. The active ingredient works as an inhibitor for acetylcholine receptors found in eccrine glands. Since it is able to reduce the stimulation of these receptors, it can indirectly decrease the rate at which a person sweats. The availability of a new therapeutic approach to treat this condition is a positive improvement for patients. Stay informed about additional medication advances for hyperhidrosis by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Crexont

The FDA has approved Crexont (carbidopa/levodopa) extended-release capsules for the treatment of Parkinson's disease. Crexont is a novel, oral formulation of carbidopa/levodopa that combines both immediate-release granules and extended-release pellets. Learn more about Crexont

Enzeevu

The FDA has approved Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration. In addition, the FDA provisionally determined Enzeevu would be interchangeable with the reference medicine as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products. Learn more about Enzeevu

Femlyv

The FDA has approved Femlyv (ethinyl estradiol/norethindrone acetate), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the US for the prevention of pregnancy as a swallowable tablet since 1968. Learn more about Femlyv

Lazcluze

The FDA has approved Lazcluze (lazertinib) with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. Learn more about Lazcluze

Leqselvi

The FDA has Leqselvi (deuruxolitinib) 8mg tablets for the treatment of adults with severe alopecia areata. Learn more about Leqselvi

Livdelzi

The FDA has approved Livdelzi (seladelpar) for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Learn more about Livdelzi

Lymphir

The FDA has approved Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy. Learn more about Lymphir

Neffy

The FDA has approved Neffy (epinephrine) nasal spray, 2mg, for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30kg (66 lbs). Learn more about Neffy

Nemluvio

The FDA has approved Nemluvio (nemolizumab) for adult patients with prurigo nodularis. Learn more about Nemluvio

Niktimvo

The FDA has approved Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease. Learn more about Niktimvo

Opipza

The FDA has approved Opipza (aripiprazole) oral film, an atypical antipsychotic indicated for treatment of schizophrenia in patients aged 13 years and older; adjunctive treatment of major depressive disorder in adults; irritability associated with autistic disorder in pediatric patients aged 6 years and older; and treatment of Tourette's disorder in pediatric patients aged 6 years and older. Learn more about Opipza

Tecelra

The FDA has approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA authorized companion diagnostic devices. Learn more about Tecelra

Voranigo

The FDA has approved Voranigo (vorasidenib) tablets for the treatment of adult and pediatric patients aged 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery, including biopsy, sub-total resection, or gross total resection. Learn more about Voranigo

Yorvipath

The FDA has approved Yorvipath (palopegteriparatide) for the treatment of hypoparathyroidism in adults. Learn more about Yorvipath

Yutrepia

The FDA has granted tentative approval for Yutrepia (treprostinil) inhalation powder for patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Learn more about Yutrepia

Zurnai

The FDA has approved Zurnai (nalmefene) injection for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older. Learn more about Zurnai

FDA New Formulations

Erzofri

The FDA has approved Erzofri (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. Learn more about Erzofri

Tezruly

The FDA has approved Tezruly (terazosin) oral solution, for the treatment of signs and symptoms of benign prostatic hyperplasia and for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. Learn more about Tezruly

Zunveyl

The FDA has approved Zunveyl (benzgalantamine) for the treatment of mild-to-moderate Alzheimer's disease (AD). Zunveyl is a prodrug of AD treatment galantamine and an acetylcholinesterase inhibitor. Learn more about Zunveyl

FDA New Indications

Brineura

The FDA has approved Brineura (cerliponase alfa) to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 deficiency. Previously, Brineura was indicated in symptomatic children aged 3 years and older with late infantile CLN2 disease. This expanded indication now includes children of all ages with CLN2 disease, regardless of whether they are symptomatic or presymptomatic. Learn more about Brineura

Darzalex Faspro

The FDA has approved Darzalex Faspro (daratumumab/hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant. Learn more about Darzalex Faspro

Fabhalta

The FDA has approved Fabhalta (iptacopan) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression. Learn more about Fabhalta

Fibryga

The FDA has approved an additional indication for Fibryga (fibrinogen [human]) for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency. Learn more about Fibryga

Furoscix

The FDA has approved Furoscix (furosemide) injection for treatment of congestion due to fluid overload in adult patients with chronic heart failure, regardless of NYHA functional class. Learn more about Furoscix

Imfinzi

The FDA has approved Imfinzi (durvalumab) in combination with chemotherapy for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. Learn more about Imfinzi

Jemperli

The FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient/microsatellite stable tumors who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options. Learn more about Jemperli

Kisqali

The FDA has approved an expanded indication for Kisqali (ribociclib) tablets for the treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or with disease progression following endocrine therapy. Learn more about Kisqali

Palforzia

The FDA has approved Palforzia (peanut (arachis hypogaea) allergen powder-dnfp) to include initiation of treatment, up-dosing, and maintenance in individuals aged 1 through 3 years with a confirmed diagnosis of peanut allergy to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Palforzia has been approved since January 2020 for initiation of treatment in individuals aged 4 through 17 years with a confirmed diagnosis of peanut allergy with up-dosing and maintenance in individuals aged 4 years and older. Learn more about Palforzia

Xembify

The FDA has approved an expanded label for Xembify (immune globulin subcutaneous human-klhw) to include treatment-naïve patients with primary humoral immunodeficiencies. Learn more about Xembify

FDA Recalls

Aurobindo Healthy Living Migraine Relief

Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot of Healthy Living Migraine Relief, acetaminophen 250mg, aspirin 250mg, and caffeine 65mg tablets, to the consumer level as sold through Amazon within the US market, due to the product missing the manufacturer label. Learn more about the Aurobindo Healthy Living Migraine Relief recall

B. Braun Sodium Chloride

B. Braun Medical Inc. is voluntarily recalling two lots of 0.9% sodium chloride for injection USP 1000mL in E3 containers within the US, to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers. Learn more about the B. Braun sodium chloride recall

Baxter Heparin Sodium in Sodium Chloride

Baxter International Inc. is voluntarily recalling one lot of heparin sodium in 0.9% sodium chloride injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235. Learn more about the Baxter heparin sodium in sodium chloride recall

Boulla Boom Max

Boulla LLC is voluntarily recalling lot number 230811, exp 8/11/25 of Boom Max capsules packaged in 10-count blisters packaged in a carton, to the consumer level. Boulla was notified by Amazon that the product was found to be tainted with sildenafil. Learn more about the Boulla Boom Max recall

Veata Endurance Pro Energy Boost

Veata LLC is voluntarily recalling lot 230811, Exp 8/11/25 of Endurance Pro Energy Boost capsules, packaged in 10-count blisters in a cardboard carton, to the consumer level. Veata LLC was notified by Amazon that the products were found to be tainted with sildenafil. Learn more about the Veata Endurance Pro Energy Boost recall

FDA Alerts

Chemical Peel Skin Products

The FDA is warning consumers not to purchase or use certain chemical peel skin products without appropriate professional supervision due to risk of serious skin injuries. The agency has not approved any chemical peel products, and consumers should only consider using chemical peel products under the supervision of a dermatologist or licensed and trained practitioner. Learn more about the chemical peel skin products alert

Compounded Injectable Semaglutide Products

The FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and healthcare providers miscalculating doses of the drug. Learn more about the compounded injectable semaglutide products alert

Unapproved Inhalant Products

The FDA is warning consumers not to purchase or use certain inhalants, which are unapproved drugs marketed to promote alertness and boost energy. These products primarily contain ammonia. Inhaling ammonia can quickly lead to coughing, airway constriction, and eye, nose, and throat irritation. Learn more about the unapproved inhalant products alert

September 2024