Latest news with #SeverityofAlopeciaTool


Medscape
3 hours ago
- Health
- Medscape
FDA Puts Alopecia Treatment on Fast Track
The FDA has granted a 'Fast Track' designation to rezpegaldesleukin (REZPEG) as a treatment for severe-to-very severe alopecia areata, according to a press release from the manufacturer, Nektar Therapeutics. The indication applies to adults and children aged 12 years or older weighing at least 40 kg. REZPEG is a novel biologic that targets 'the interleukin-2 receptor complex in the body to stimulate proliferation of inhibitory immune cells known as regulatory T cells,' according to the company. The Fast Track designation was created to help bring important new treatments to patients as soon as possible and is granted to investigational therapies that may address unmet medical needs for serious conditions, according to the press release. REZPEG is being evaluated in the ongoing Rezolve AA phase 2b study in patients with alopecia areata. In the study, 90 patients with severe-to-very severe alopecia areata (defined as scalp involvement of 50% or more) who were not previously treated with a JAK inhibitor or another biologic were randomized to two different doses of REZPEG or placebo. It will be a self-administered injection, the company said. The primary efficacy endpoint is the mean percent change in the Severity of Alopecia Tool (SALT) score at the end of the 36-week induction period, according to the company. Secondary endpoints include the proportion of participants with reductions in SALT scores of 50% or more at 36 weeks and other timepoints, as well as the mean percent improvement in SALT score at multiple timepoints and the proportion of patients achieving an absolute SALT score ≤ 20. Data from the trial are scheduled to be reported in December 2025, according to the company. The designation follows a previous Fast Track designation for the product as a treatment for moderate-to-severe atopic dermatitis in February.

Business Standard
14-07-2025
- Business
- Business Standard
Sun Pharma launches hair loss drug Leqselvi in US after patent settlement
The delay in Sun Pharma's launch of Leqselvi in the US was caused by a patent infringement case, which was later settled in a US court with Incyte Corp New Delhi Sun Pharmaceutical has launched a new medicine for severe alopecia areata, called Leqselvi, in the United States. Alopecia areata is a condition in which the immune system attacks hair follicles, leading to hair loss on the scalp as well as other parts of the body. 'Leqselvi is an important step forward for people living with severe alopecia areata,' said Richard Ascroft, CEO of Sun Pharma North America. 8 mg Leqselvi tablets for severe alopecia areata is now available by prescription across the US. The delay in Sun Pharma's launch of Leqselvi in the US was caused by a patent infringement case, which was later settled in a US court with Incyte Corp, as reported by Reuters. The drug underwent two clinical trials, THRIVE-AA1 and THRIVE-AA2, involving 1,223 adults between 18 and 65 years of age. The trials were conducted in the US, Canada, and Europe. Hair regrowth was measured over a period of 24 weeks using a scoring system known as the Severity of Alopecia Tool (SALT), according to the company's statement. Shrikant Akolkar, analyst at Nuvama Institutional Equities, said the drug could generate up to $400 million in sales by FY30, with peak sales potential of $900 million, and boost growth in Sun's key US market, according to Reuters. The National Alopecia Areata Foundation (NAAF) welcomed the launch. Its President, Nicole Friedland, said the new treatment offers hope to many people dealing with the emotional and social impacts of hair loss. Sun Pharmaceutical is also offering a 'Leqselvi Support Program' to help patients access the medicine. Eligible patients may be able to receive the drug for as little as $0 for up to two years. The program also includes personal guidance and support throughout the treatment process. 'The clinical evidence for Leqselvi is truly compelling, demonstrating consistent efficacy," said Arash Mostaghimi, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women's Hospital. However, Leqselvi does carry certain risks. It may cause side effects such as infections, acne, headaches, or more serious health issues. Doctors are advised to screen patients thoroughly before and during treatment. Alopecia areata affects nearly 2.5 per cent of people in the United States during their lifetime. According to figures cited in the company's release, the condition also affects a similar percentage of the global population. The scalp is the most commonly affected area, but hair loss can also occur on other parts of the body.


Time of India
12-06-2025
- Health
- Time of India
From code to cure: AI offers new hope for alopecia areata patients.
Assessment with AI: AI's predictive model aiding treatment outcomes: Live Events Robotic Hair Restoration: Innovative Treatment Approaches: 'Alopecia areata (AA) is a complex autoimmune condition that causes non-scarring hair loss.' Known to be a condition that hasn't had much success in terms of discovering a cure that is 100% effective. With the emergence of artificial intelligence in the field of dermatology, its recent advancements in machine learning and AI-driven technologies are paving the way for therapies on an individual level, offering new hope to patients across the a standardized scale was prepared, called the Severity of Alopecia Tool (SALT), to assess the severity of individual AA cases. This standardized scale is subject to human interpretation and variability. With recent studies, AI systems are now capable of quantifying AA and assigning SALT scores objectively, without the process being cumbersome, time-consuming, and inconsistent while evaluating. This advancement aids the assessment protocol for AA and monitoring for treatment progress while also streamlining the diagnostic analyzes the photographs of the scalp from four angles, that is, the top, back, left, and right, and calculates the severity of AA-stricken areas on the patient's scalp via assigning a SALT (percentage of total hair lost) score. Based on these numbers, doctors assess with increased precision the current state of the patient's AA. However, this process does not inculcate forecasting how much hair will be lost by the individual over time, nor would it track its regrowth over time, unless the photographs are to be reanalyzed by other forms of specialized AI predictive features of AI can help forecast how well patients with AA might respond to their prescribed treatment. Researchers are aimed at developing an AI algorithm that can analyze close-proximity photographs of that scalp, referred to as 'trichoscopic images.' These images are taken by a trichoscope to predict which patients are more likely to foster positive AI systems are trained to recognize specific features in the trichoscopic images , such as the indicators of negative prognosis—characteristics like black dots, broken hairs, exclamation mark hairs, and tapered hairs—suggesting a negative response to treatment administered to the patient. Apart from negative prognostic indicators, the AI is also trained to identify neutral indicators, with features like yellow dots that suggest there was no response to the treatment predictive model could help clinicians to personalize the treatment plans based on the response the individual gets, making the treatment more effective and improving their chances of potential hair hair restoration, as spoken of by the American Society of Plastic Surgeons , utilizes AI-powered robots to assist in hair transplant surgeries. These robots are well-equipped with extracting individual hair follicles from the donor area, referred to as 'harvesting hair follicles,' and transplanting these follicles into areas experiencing hair loss, 'implanting hair follicles.'The integration of AI enables precision-led assessment of the position, angle, orientation, and density of hair follicles in both donor and recipient areas. It further allows developing a 3D map of the scalp to guide the robot in accurately harvesting and implanting follicles. Eventually leading to natural-looking results with minimal damage to existing have entrusted machine learning, a subset of AI, to create 'microneedle' patches embedded with manganese thiophosphate (MnPS₃), a nanoenzyme (or nanomaterial engineered to mimic the activity of natural enzymes with potential therapeutic benefits) identified by an AI subset after analyzing 91 different combinations of transition metals and other compounds that could neutralize 'reactive oxygen species,' the unstable molecules that cause oxidative stress, excessiveness of which could cause harm to hair follicles, affecting their growth further essence, the integration of AI into dermatological practices signifies new hope for individuals affected by a long-considered 'difficult-to-treat' condition. AA, affecting one's hair, can take a severe toll on one's self-expression and self-esteem, with hairstyles closely tied to personal identity and confidence. Although AI-driven solutions are now aiding in AA's diagnosis, prognosis, and personalized treatment, patients need not face situations with uncertainty anymore. For these technological advancements to continue to evolve, they shall revolutionize patient care moving forward. ( source