April 2024

PDR Drug Update 

Vasodilator Receives First Approval for Severe Frostbite

When skin is subjected to extreme cold, tissue injury from frostbite is a tremendous risk. As body temperature drops, numbing may occur, which masks the severity of the damage. In cases of dramatic injury, affected body parts may endure spontaneous or surgical amputation if there has been tissue death. The first treatment option recently approved for severe frostbite can help reduce this risk, giving medical teams a new way to help patients who may otherwise face life-changing loss of fingers or toes.

The drug known as iloprost was originally used as a treatment for pulmonary arterial hypertension. It was delivered via inhalation and worked by relaxing blood vessels in the lungs in order to help keep an adequate supply of blood pumping through them. Iloprost is a synthetic prostacyclin that inhibits platelets' ability to adhere to one another and form a hemostatic plug. This important characteristic has also been found to be effective for keeping blood flowing into tissues damaged by frostbite. When frostbite is severe, all skin layers and underlying tissues are affected. The color of the skin will change, turning white or grayish blue as it freezes and blood is not able to flow properly. Through the new approval for Aurlumyn (iloprost), the medication will now be able to be used to reverse the constriction in blood vessels caused by frostbite.

The clinical trial for the approval involved 47 adults with severe frostbite. After a week of treatment either with (a) another drug, (b) iloprost alone, or (c) another drug plus iloprost, all patients who were administered iloprost alone cleared a predictive bone scan used to determine if amputation of toes or fingers would be necessary. The bone scan anomaly that is expected to be present in cases of frostbite was not present when iloprost was the sole medication, and was present in significantly fewer patients when another drug plus iloprost was used. The efficacy demonstrated by these results proved the drug's benefits and led to its approval. Administration of iloprost occurs in a healthcare setting through continuous intravenous infusion for 6 hours each day for up to no more than eight consecutive days.

Having a tool like iloprost that can become the new standard of care for patients who previously would have to face the loss of their extremities is a boon for healthcare providers. Stay informed about additional advances in drug information 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

Duvyzat

The FDA has approved Duvyzat (givinostat), a novel histone deacetylase inhibitor, for the treatment of patients aged 6 years or older with Duchenne muscular dystrophy. Learn more about Duvyzat

Jubbonti

The FDA has approved Jubbonti (denosumab-bbdz) as a denosumab biosimilar to treat all indications of its reference medicine: postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Learn more about Jubbonti

Lenmeldy

The FDA has approved Lenmeldy (atidarsagene autotemcel) for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile, or early symptomatic early juvenile—collectively referred to as early-onset—metachromatic leukodystrophy. Learn more about Lenmeldy

Rezdiffra

The FDA has approved Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Learn more about Rezdiffra

Tevimbra

The FDA has approved Tevimbra (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Learn more about Tevimbra

Tryvio

The FDA has approved Tryvio (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure in adult patients who are not adequately controlled on other drugs. Learn more about Tryvio

Wyost

The FDA has approved Wyost (denosumab-bbdz) as interchangeable with its reference medicine. Wyost is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. Learn more about Wyost

FDA New Indications

Breyanzi

The FDA has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor. Learn more about Breyanzi

Brukinsa

The FDA has granted accelerated approval to Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Learn more about Brukinsa

Edurant PED

The FDA has approved Edurant PED (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) aged at least 2 years and weighing at least 14kg and less than 25kg. Learn more about Edurant PED

Livmarli

The FDA has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients aged 5 years and older with progressive familial intrahepatic cholestasis. Learn more about Livmarli

Wegovy

The FDA has approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight. Learn more about Wegovy

FDA New Combinations

Iclusig + Chemotherapy

The FDA has approved the supplemental new drug application for Iclusig (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy. Learn more about Iclusig + chemotherapy

Opdivo + Cisplatin and Gemcitabine

The FDA has approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Learn more about Opdivo + cisplatin and gemcitabine

FDA Recalls

Brassica Eye Ointment Products

Brassica Pharma Pvt. Ltd. is voluntarily recalling certain eye ointment products with expiration dates ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the FDA. Learn more about the Brassica eye ointment products recall

Par Pharmaceutical Treprostinil

Endo International announced today that one of its operating companies, Par Pharmaceutical, is voluntarily recalling one lot of treprostinil injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution. Learn more about the Par Pharmaceutical treprostinil recall

Pyramid Wholesale Dietary Supplements

Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared sildenafil and/or tadalafil. Learn more about the Pyramid Wholesale dietary supplements recall

Labeling Updates - No updates this month