New Therapeutics

THURSDAY, Feb. 15, 2024 (HealthDay News) -- Aurlumyn (iloprost), a vasodilator, has been approved by the U.S. Food and Drug Administration to treat severe frostbite. The injected medication lowers the risk for finger or toe amputation."This approval provides patients with the first-ever treatment option for severe frostbite," Norman Stockbridge, M.D., director of the Division of Cardiology and Nephrology in the FDA Center for Drug Evaluation and Research, said in an agency news release. "Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one's frostbitten fingers or toes."The FDA approval hinged on the results of a <a target="_blank" rel="noopener noreferrer" href="https://www.nejm.org/doi/full/10.1056/NEJMc1000538">trial</a> that randomly assigned 47 adults with severe frostbite, all of whom received intravenous aspirin and standard of care, into one of three treatment groups.Group 1 received Aurlumyn intravenously for six hours a day for up to eight days. The two other groups received other medications that are not approved for frostbite, given with Aurlumyn (group 2) or without Aurlumyn (group 3). The main measure of efficacy was a bone scan taken seven days after the initial frostbite that predicted the need for amputation of at least one finger or toe. None of the 16 patients receiving Aurlumyn alone was found to need amputation compared with 19 percent of patients in group 2 and 60 percent of patients in group 3.The most common side effects with Aurlumyn included headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension. Aurlumyn also carries a warning noting that it may cause symptomatic low hypotension, the FDA noted.Approval of Aurlumyn was granted to Eicos Sciences.<a target="_blank" rel="noopener noreferrer" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-treat-severe-frostbite">More Information</a>

Newly approved medication lowers the need for amputation of fingers or toes

FDA Approves Aurlumyn for Severe Frostbite

FRIDAY, Dec. 22, 2023 (HealthDay News) -- From 2012 to 2022, innovative dermatologic drug development increased, according to a research letter published online Dec. 20 in JAMA Dermatology.Samir Kamat, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues characterized the frequency and degree of innovation of new dermatologic drugs (topical or systemic) approved by the U.S. Food and Drug Administration from 2012 to 2022.The researchers identified 52 new drug applications and 26 supplemental new indications approved by the FDA. Among the new drugs, 21 percent were categorized as first in class and 25 percent as first in indication. Health technology assessment organizations in Germany, Canada, or France rated 39 percent of new drugs as clinically useful or having high added therapeutic benefit and 30 percent of the supplemental new indications as clinically useful or having high added therapeutic benefit."This study suggests that innovative dermatologic drug development may have increased over the past decade, offering promise for patients with skin disease," the authors write. "However, these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need."Several authors disclosed ties to industry.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/article-abstract/2812731">Abstract/Full Text (subscription or payment may be required)</a>

Furthermore, nearly four in 10 new dermatologic drug approvals were deemed clinically useful

One in Five New Dermatology Drugs Were First in Class Over the Past Decade

FRIDAY, Dec. 15, 2023 (HealthDay News) -- In a recent trial, a new melanoma vaccine, mRNA-4157 (V940), when taken in combination with Keytruda (pembrolizumab), was found to be effective in battling the deadly skin cancer.People with advanced melanomas who received the vaccine plus Merck's cancer drug Keytruda were 49 percent less likely to die or have their cancer return after three years than those who were given only Keytruda, vaccine maker Moderna Inc. announced Friday."Importantly for this technology, the... study was the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show a significant benefit over Keytruda alone in adjuvant melanoma," Moderna Senior Vice President Kyle Holen, M.D., said in a company news release. "We look forward to sharing these data with people impacted by this disease and the broader scientific community."The findings are based on an ongoing randomized trial involving 157 patients with high-risk stage 3/4 melanoma who first had surgery to completely remove cancerous growths. Patients received 1 mg of the mRNA vaccine every three weeks for a total of nine doses, along with 200 mg of Keytruda every three weeks for about a year. Their outcomes were compared to those using Keytruda alone for approximately a year.The companies have already begun phase 3 trials of the vaccine-drug combo, and the U.S. Food and Drug Administration has designated the treatment as a breakthrough therapy to speed its development and review.<a target="_blank" rel="noopener noreferrer" href="https://investors.modernatx.com/news/news-details/2023/Moderna-And-Merck-Announce-mRNA-4157-V940-In-Combination-with-KeytrudaR-Pembrolizumab-Demonstrated-Continued-Improvement-in-Recurrence-Free-Survival-and-Distant-Metastasis-Free-Survival-in-Patients-with-High-Risk-Stage-IIIIV-Melanoma-Following-Comple/default.aspx">More Information</a>

Patients who received the vaccine plus Keytruda were 49 percent less likely to die or have their cancer return after three years

Efficacy Shown for New Melanoma Therapeutic Vaccine

WEDNESDAY, Dec. 6, 2023 -- Bimekizumab seems beneficial for treating palmoplantar pustulosis (PPP), palmoplantar plaque psoriasis with pustules, and synovitis, acne, pustulosis, hyperostosis, osteitis (SAPHO) syndrome, according to a study published online Dec. 6 in JAMA Dermatology.Thierry Passeron, M.D., Ph.D., from the Centre Hospitalier Universitaire de Nice in France, and colleagues examined the effectiveness of bimekizumab in treating PPP and palmoplantar plaque psoriasis with pustules in a case series of 21 adults: 11 with PPP and 10 with palmoplantar plaque psoriasis with pustules, treated at seven tertiary dermatology centers in France.The researchers found that apart from two patients who received bimekizumab as first systemic therapy, none of the other patients had responded to previous systemic treatment and/or had adverse events leading to discontinuation of treatment. Seventeen patients achieved complete clearance (Investigator Global Assessment [IGA] score of 0) in one to four months. Three and one patients achieved an IGA score of 1 and 2, respectively. Three of the PPP patients also presented with acrodermatitis continua of Hallopeau. For these patients, after four to six months of bimekizumab treatment, nail involvement showed 50 to 70 percent improvement. Two patients had SAPHO syndrome; complete clearance of skin lesions and improvement in joint pain were seen for both. Oral antifungal agents successfully treated four patients with candidiasis. No patients stopped bimekizumab due to adverse events."A prospective placebo-controlled randomized clinical trial is warranted to confirm these encouraging initial results," the authors write.Several authors disclosed ties to biopharmaceutical companies, including UCB, the manufacturer of bimekizumab.

Case series also shows improvement for patients with palmoplantar plaque psoriasis with pustules, SAPHO syndrome

Bimekizumab Beneficial for Treating Palmoplantar Pustulosis

THURSDAY, Nov. 2, 2023 (HealthDay News) -- The U.S. Food and Drug Administration has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.The approval includes indications for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn disease, and moderately to severely active ulcerative colitis. Additionally, the approval includes indications for pediatric patients (aged 6 years and older) with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and those with active psoriatic arthritis.Approval of Wezlana was based on a review of scientific evidence that showed it is highly similar to Stelara in terms of safety, purity, and potency. Evidence from chemical and biological tests and biological assays confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy). Additionally, evidence included comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. Infection is the most serious known side effect in both drugs.&nbsp;"Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases," Nikolay Nikolov, M.D., from the FDA Center for Drug Evaluation and Research, said in a statement. "Today's approval could have a meaningful impact for patients managing their disease."Approval of Wezlana was granted to Amgen.

Approval of the biosimilar allows for interchangeable use with Stelara in both adult and pediatric patients

FDA Approves Wezlana for Multiple Inflammatory Diseases

In this episode of Derms and Conditions, our host, James Q. Del Rosso, DO, interviews pediatric dermatologist Lisa Swanson, MD, live at Winter Clinical Miami 2024 to review conference highlights and discuss diagnosing and treating molluscum contagiosum, herpes labialis in the adolescent population, and newer and emerging therapies for chronic skin diseases like atopic dermatitis and acne.

In this episode of Derms and Conditions, our host, James Q. Del Rosso, DO, interviews pediatric dermatologist Lisa Swanson, MD, live at Winter Clinical Miami 2024 to review conference highlights and discuss diagnosing and treating molluscum contagiosum, herpes labialis in the adolescent population, and newer and emerging therapies for chronic skin diseases like atopic dermatitis and acne.Dr Swanson discusses the recent FDA approval of cantharidin and berdazimer gel for molluscum contagiosum and the challenges of diagnosing single lesions. She highlights the importance of providing accurate information to schools and daycares about the contagiousness of the virus and the unnecessary quarantine measures that are often enforced.The pair share their excitement about the ability to profoundly impact patients' lives with newer therapies for chronic conditions, particularly bimekizumab, an anti-IL17A and anti-IL17F for plaque psoriasis, and oral deucravacitinib, a TYK2 inhibitor for plaque psoriasis that now has 3-year efficacy and safety data.They also discuss the presentation of herpes labialis in adolescents, with Dr Swanson emphasizing the marked severity of the primary outbreak, the importance of counseling these patients on managing outbreaks, and making efforts to destigmatize this condition among this population.Dr Swanson also looks forward several anticipated FDA approvals which include lebrikizumab for atopic dermatitis, both topical tapinarof and topical roflumilast also for atopic dermatitis including young children, and the approval of topical ruxolitinib extended to younger children. She also emphasizes that emerging access to acne medications in children of younger ages is important as puberty develops earlier. She discusses the effectiveness of clindamycin, benzoyl peroxide, and adapalene as a once daily combination treatment for acne and the availability of topical clascoterone, an androgen receptor inhibitor, which can be used twice daily for both adolescent girls and boys with acne.They conclude with a discussion on the importance of character and kindness in the field of dermatology based on a presentation at the meeting by special guest speaker Lori Greiner, which Dr Swanson demonstrates through her expressed willingness to help those without access to a pediatric dermatologist and an open-door policy for clinical consultation.

New Therapeutics Condition Center

Featured in New Therapeutics

New Therapeutics Episodes to Explore

Highlights of Winter Clinical Miami 2024

New Therapeutics News & Research

FDA Approves Aurlumyn for Severe Frostbite

One in Five New Dermatology Drugs Were First in Class Over the Past Decade

Efficacy Shown for New Melanoma Therapeutic Vaccine