Your source for the latest industry trends and drug information news.
Volume 7 | Issue 14
July 15, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD & Christina Ramsay, PharmD
Contributing Authors: Xintian Wu, PharmD/MBA Candidate, and Jessica Lin PharmD/MBA Candidate
On June 16, 2025, the U.S. Food and Drug Administration (FDA) approved Andembry® (garadacimab-gxii) for the prevention of attacks of hereditary angioedema (HAE) in patients 12 years and older. Andembry® is the first and only medication that works to prevent attacks of HAE by targeting factor XIIa, an enzyme involved in various systems of the body associated with blood clotting and inflammation. Blocking factor Xlla prevents HAE attacks by inhibiting the onset of the cascade of inflammation and swelling. HAE is a rare and serious genetic disease, occurring in approximately 1 in 50,000 individuals in the United States, and involves recurrent attacks of swelling that can involve the face, hands, feet, as well as internal organs, including the gastrointestinal tract and airway. HAE attacks involving the airway can be life-threatening due to swelling and breathing restriction, which can lead to suffocation. Various triggers can set off an HAE attack, such as stress or illness.
Andembry® is a monoclonal antibody designed to mimic the body’s own natural proteins. The subcutaneous (under the skin) injection may be self-administered, after proper instruction from a health care provider. An initial loading dose of 400mg is recommended, followed by a maintenance dose of 200mg once a month. Andembry® was evaluated for safety and efficacy in a phase 3 placebo-controlled study, called VANGUARD. Of the 64 patients enrolled in the six-month trial, 62% experienced zero HAE attacks during the treatment period, and Andembry® significantly reduced HAE attacks by 89% compared to treatment with placebo. Side effects of Andembry® include redness, itching, bruising at the injection site, stomach pain, runny or stuffy nose, sneezing and watery eyes.
On June 18, 2025, the FDA issued a drug safety warning that the topical patch Transderm Scōp (scopolamine transdermal patch) can cause an increase in body temperature, leading to potentially severe heat-related medical complications. Transderm Scōp is a prescription-only topical patch that is FDA approved for use in adults for the prevention of nausea and vomiting associated with motion sickness or post-operative nausea and vomiting (PONV). The patch is applied behind the ear for up to three days. Transderm Scōp is only FDA-approved for use in adults but may sometimes be prescribed “off-label”, which means it is being used to treat an indication that it is not FDA-approved to treat, in pediatric patients when medically necessary to help manage excessive drooling in conditions like cerebral palsy. Most of the cases of increased body temperature and serious heat related complications that have been reported to date have occurred in pediatric patients (17 years or younger) and in older adults (60 years and older) who may be at greater risk for adverse reactions from changes in their body temperature. As a result, the FDA has required the manufacturer of Transderm Scōp to update the package labeling for their product to include a warning about this risk. An abnormally high body temperature, also called hyperthermia, is a serious medical emergency requiring immediate attention and possibly hospitalization. Heat-related complications may be severe and can include confusion, loss of consciousness, coma or death. If patients using the patches experience symptoms of hyperthermia such as increased body temperature or reduced sweating, they should remove Transderm Scōp from their skin immediately and contact their health care provider.
On June 20, 2025, the FDA approved Dupixent® (dupilumab) for the treatment of bullous pemphigoid (BP) in adults. Dupixent® is already FDA approved for the treatment of other skin conditions and several diseases of the gastrointestinal tract and respiratory system, including atopic dermatitis, chronic hives, asthma and chronic obstructive pulmonary disease. BP is a rare chronic autoimmune condition affecting the skin. BP primarily occurs in older adults and causes redness, painful blistering, itching and rash. Initial therapy may include short-term treatment with topical or oral corticosteroids to relieve itching and help heal skin blistering. There is currently no cure for BP, so the goal of treatment is symptom management and disease remission. If left untreated, complications of BP may include skin infection and scarring.
Dupixent® was evaluated for safety and efficacy in a randomized double-blind placebo-controlled clinical trial that compared Dupixent® to standard of care therapy with oral corticosteroids in 106 patients with BP. Dupixent® performed better than the standard of care as shown by disease remission results, with 18% of patients receiving Dupixent® experiencing disease remission compared to 6% of patients receiving oral corticosteroids. Patients treated with Dupixent® also achieved better results in itch reduction (38% compared to 11% of those treated with oral corticosteroids). Side effects observed in the trial included joint pain, eye inflammation or blurred vision, and viral infections. Dupixent® is an injectable medication and may be self-injected under the skin. The dose for BP is an initial injection of 600mg, followed by 300mg injections every two weeks.
New Drug: Lynozyfic™ (linvoseltamab-gcpt)
Intravenous injection approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four previous types of therapy. [7/2/2025 – Regeneron Pharmaceuticals, Inc.]
Tasigna® (nilotinib)
Indication: For the treatment of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML).
Dosage Form/Strength: 50mg, 150mg, 200mg capsule
Average Wholesale Price (AWP): Generic = $13,219 | Brand = $13,915
