FDA Approves Dupilumab for Bullous Pemphigoid
Dupilumab has been approved by the FDA for the treatment bullous pemphigoid in adults, the manufacturer Regeneron announced.
Dupilumab (Dupixent), a human monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is now approved in the United States for eight diseases, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis. Dupilumab, administered by subcutaneous injection, is the first targeted treatment to be approved in the United States for bullous pemphigoid, according to the company's press release.
The approval follows a supplemental New Drug Application filed with the FDA in February 2025 and is based on data from ADEPT, a pivotal phase 2/3 study in more than 100 adults with moderate-to-severe bullous pemphigoid known as, according to Regeneron. The study's design was published in Advances in Therapy.
In the study, 106 patients were randomized to 300 mg of subcutaneous dupilumab or a placebo injection every 2 weeks, added to standard-of-care oral corticosteroids. At 36 weeks, 18.3% of patients in the dupilumab group achieved the primary endpoint of sustained disease remission compared with 6.1% of those in the placebo group. The study defined sustained remission as a combination of complete clinical remission and no relapse after an oral corticosteroid taper by 16 weeks, with no use of rescue therapy during the study period.
More patients treated with dupilumab achieved a clinically meaningful reduction in itching (38.3% vs 10.5%), and the median cumulative oral corticosteroid dose in the dupilumab-treated group was 2.8 g vs 4.1 g in the placebo group, according to the company release.
The most common adverse events among patients receiving dupilumab (affecting 2% or more) compared with those receiving placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. One patient receiving dupilumab also developed acute generalized exanthematous pustulosis; no cases were reported among those receiving placebo.
The dupilumab study was funded by Sanofi and Regeneron, the companies co-developing dupilumab.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
30 minutes ago
- Yahoo
Intel alum to get $1.9M bonus as newly-minted Ciena CFO
This story was originally published on CFO Dive. To receive daily news and insights, subscribe to our free daily CFO Dive newsletter. Intel alum Marc Graff will receive a $1.9 million cash bonus upon taking the top financial seat for high-speed optical networking firm Ciena, with the move effective Aug. 1, the company said Thursday in a securities filing. Graff, who most recently served as CFO for semiconductor company Altera, is also set to receive a one-time replacement equity grant with a target delivered value of $10.4 million, both of which are intended 'to partially compensate Mr. Graff for the value of certain near-term cash and equity incentives and certain long- term equity incentive compensation that he forfeited upon resignation from his prior employer,' according to the filing. One quarter of the grant will vest a year following his becoming CFO, while the remainder will vest over a three-year period, the company said. Graff will succeed 18-year company veteran James Moylan in the position, the Hanover, Maryland-based company said in a press release. Moylan, who announced his intent to retire last September, will stay on until Aug. 28 to assist with a smooth transition, the company said. 'For the past 18 years and an incredible 70 earnings calls, Jim has been an incredible partner and member of our executive team with a lengthy list of significant contributions to the growth and the performance of our business,' CEO Gary Smith said of Moylan's tenure as CFO during the company's most recent earnings call on June 5. Prior to Altera, which he joined in January 2024 as its finance chief, Moylan's successor Graff logged a 26-year career at software giant Intel, serving in such roles as its corporate VP, CFO and chief operating officer, data platforms group, and VP, head of financial planning & analysis, according to his LinkedIn profile. As well as the $1.9 million cash bonus and one-time equity grant, Graff will also receive an annual base salary of $650,000 as Ciena's CFO, according to the filing with the Securities and Exchange Commission. He will also be eligible for an annual target bonus opportunity of 100% of his base salary. For fiscal 2026, Graff will also receive an equity award with a target delivered value of $3.9 million, the company said. The CFO swap comes as the optical networking firm is looking to take advantage of a rise in data center and cloud spending driven by the artificial intelligence boom. For its Q2 of fiscal 2025 ended May 3, Ciena saw a nearly 24% jump in net revenue year-over-year to reach $1.1 billion — with revenues from cloud providers a 'key driver,' CEO Smith said during the company's earnings call. Ciena also reported GAAP net income of $9 million for the quarter, compared to a net loss of $16.8 million for the prior year period, according to its earnings results published June 5. The company achieved record direct cloud provider revenue for its Q2, a segment which represented 38% of total revenue, Smith said, according to a transcript. The results are 'really highlighting the accelerating investments in AI infrastructure and our leadership in addressing this demand,' Smith said, noting that three out of the five top customers for the quarter were cloud providers, underscoring their sustained investments in AI infrastructure and network expansion.' Data center capital expenditures skyrocketed by 53% to reach $134 billion in the first three months of this year, CFO Dive sister publication CIO Dive reported, citing a survey by Dell'Oro research group. The growth was primarily driven by 'hyperscaler spending' on AI infrastructure with AWS, Google, Meta and Microsoft — the four companies with the largest cloud footprints — accounting for 44% of Q1 spending in the space, according to the report. However, as Ciena aimed to capitalize on the swell in spending, the optical networking provider also faced headwinds from the shifting tariff environment in its Q2, CFO Moylan said during the earnings call. Amid the 'dynamic' tariff environment, combined with a need for Ciena to adjust its billing and customer systems, the company 'absorbed a net impact to our bottom line in the mid-single-digit millions of dollars in the quarter,' Moylan said. The company did not immediately respond to requests for comment. Recommended Reading Wise CFO credits customer growth for 280% profit jump Fehler beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten
Forbes
31 minutes ago
- Forbes
The Triple Threat Draining Workforce Productivity And Mental Health
Productivity and mental health are taking a hit for three reasons. Numbers never lie: it's why CEOs obsess over revenue targets, operational metrics, quarterly growth, and more. Yet beneath the spreadsheets and data dashboards lies an invisible crisis quietly eroding organizational strength and productivity: the deteriorating mental health and emotional resilience of today's workforce. A comprehensive 2025 State of the Workforce Report by meQuilibrium, surveying 5,477 employees across various industries, identified a troublesome "triple threat" that undermines employee performance and well-being: uncertainty, pessimism, and psychological disconnection. These aren't mere HR concerns; they're operational risks with quantifiable financial impacts. The data paints a clear picture: These challenges are silently sabotaging productivity, further inflating turnover costs, and increasingly impacting employee well-being. The Real Cost Of The Triple Threat Uncertainty alone led to a 68% increase in productivity impairment. Employees facing high uncertainty stress experience twice the risk of generalized anxiety disorders and nearly double the rate of burnout, costing American companies between $4,000 and $21,000 per employee annually, according to a study in the American Journal of Preventive Medicine. Pessimism compounds this impact significantly. Workers with negative job outlooks report a 64% decrease in productivity, alongside a staggering 128% higher risk of depression and 108% higher risk of anxiety compared to optimistic colleagues. The psychological disconnect further exacerbates productivity losses. Even employees displaying no signs of disconnect report an average productivity impairment of 29%, while severely disconnected employees experience impairment rates of up to 66%. This triple threat isn't fleeting; it's systemic and escalating, making employee mental health and emotional resilience one of your organization's significant, yet often overlooked, financial liabilities. Foundational Strategies To Improve Productivity And Mental Health A company thrives when its people thrive. Amid volatility and continuous disruptions, the greatest threat to any organization is a workforce characterized by stress, negativity, disengagement, and poor health. However, this crisis presents opportunities to cultivate resilience and strength. While each company is unique, these foundational actions can universally elevate employee well-being and productivity: Fitness offers more than aesthetics. It's a strategic investment. CEOs like Bob Iger strongly advocate for fitness because it improves their mood, focus, emotional regulation, executive presence, and resilience. To build a health-driven culture, leaders must actively model wellness practices. Sleep is equally critical. Improved sleep and recovery improve individuals' decision-making and emotional regulation and reduce team volatility. Prioritizing a health-first culture also serves as a strong talent attractor and retention tool. Ambiguity breeds stress, especially with technological disruptions like AI, which create concerns about job stability. Clear and consistent communication significantly mitigates uncertainty. Leaders must frequently reiterate their vision in a way that integrates each person seamlessly. Also key is establishing priorities and performance expectations along with transparency in explaining the rationale behind decisions. Vulnerability and candor strengthen trust, which further reduces speculation and disengagement among employees and investors alike. Soft skills matter significantly, even in the data-driven corporate world. As highlighted in the report, empathetic managers reduce uncertainty stress by 37% and disconnect by nearly 50%. CEOs and senior leaders can actively cultivate empathy through the following: Better Mental Well-Being Equals Improved Productivity Addressing the triple threat isn't merely beneficial—it's critical. The modern workforce faces numerous challenges that threaten employees' mental health and productivity. With ongoing volatility and persistent uncertainty, investing in mental health and resilience becomes not just advantageous but essential. As technology democratizes and ceases to offer unique competitive advantages, the companies that will lead tomorrow are those who invest significantly in their people's well-being today.
Yahoo
32 minutes ago
- Yahoo
5 Things You Must Do When Your Net Worth Reaches $1 Million
Many dream about what they would do if they had a million dollars. In the dream, this might come by way of an easy win on a lottery ticket or a large inheritance, yet for lots of Americans, it's hard work, dedication and perseverance that allows them to reach that goal over time. However, once they find their net worth is at $1 million, they are often clueless as to what to do next. For You: Read Next: If you are on the path to reaching that great financial height, you want to make sure your next moves are strategic, so you do not endanger the wealth you've generated and, in many cases, can even continue to grow it. Here are five things you must do when your net worth reaches $1 million. Kerry Keihn, a financial advisor at Earth Equity Advisors, stressed the importance of understanding how a $1 million net worth can take shape, as there are many forms. 'Is it primarily home equity, investment accounts or sitting in cash?' asked Keihn. 'Real wealth isn't just about reaching a number — it's about how well your assets align with your financial needs and values. Understanding your breakdown is crucial for determining next steps.' As an example, Keihn said, 'If a large portion of your $1 million is in cash in a single bank account, you'll want to ensure you're staying within the FDIC insurance limits.' Check Out: Reaching this milestone is an opportunity to be intentional with your investments, according to Keihn. Citing a US SIF Trends Report, Keihn said, 'Many investors choose to align their portfolios with their values through sustainable, responsible and impact investing , a rapidly growing approach that now accounts for a significant share of global assets under management. 'This could mean investing in companies with strong environmental and social practices, excluding industries that don't align with personal ethics or funding solutions to global challenges like clean energy and affordable housing,' Keihn explained. 'Your investments have the power to shape the future — this is the time to ask: Do my investments align with my values?' 'Anchoring bias occurs when we rely heavily on the first piece of information we receive and fail to adjust it as we gather new insights,' explained Keihn, noting that society often treats $1 million as the ultimate financial milestone without adjusting for inflation. 'The meaning of being a millionaire has shifted over time, but the term still holds a powerful allure,' Keihn added. 'In reality, the impact of $1 million in net worth on your life depends on your financial circumstances.' Keihn said the key is to focus on whether your portfolio can support your personal goals rather than arbitrary benchmarks. One thing to be aware of with a larger portfolio is that tax efficiency becomes even more important, in Keihn's professional opinion. 'Investors should consider tax-smart strategies, like asset location, tax-loss harvesting, charitable giving — such as donor-advised funds — and sustainable withdrawal rates if they're starting to draw from their portfolio,' she said. How well do you know your financial goals, especially after accumulating such wealth? Keihn explained that reaching that milestone is the perfect time to analyze your financial plan. 'Reaching $1 million is an ideal time to reassess whether you're on track for the future you envision,' Keihn said. 'Does this milestone mean financial independence, or are adjustments needed to reach your next goal? If you don't have a formal plan, now is the time to create one.' More From GOBankingRates 5 Types of Cars Retirees Should Stay Away From Buying This article originally appeared on 5 Things You Must Do When Your Net Worth Reaches $1 Million Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
