The Food and Drug Administration has granted Eli Lilly permission for Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the United States. each year.
Today's action marks the first FDA approval of a systemic treatment, which treats the entire body rather than a specific location,) for alopecia areata.
"Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," said Kendall Marcus, director of the division of dermatology and dentistry in the FDA's Center for Drug Evaluation and Research. "Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."
“There is a significant unmet medical need for people with alopecia areata given there has never been an FDA-approved medicine," said Patrik Jonsson, Lilly's senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. "Our mission is to make life better for people living with debilitating immune-mediated diseases, and we’re delighted about what this medicine, as a first-in-disease treatment, can mean for adults with severe alopecia areata.”
Alopecia areata, commonly referred to as just alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in clumps. Olumiant is a Janus kinase inhibitor that blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.
Olumiant was originally approved in 2018 as a treatment for certain adult patients with moderately to severely active rheumatoid arthritis. Olumiant also is approved for the treatment of COVID-19 in certain hospitalized adults.
Lenny & Larry’s has launched a brand new protein bar that contains 18 g of dairy, plant protein and probiotics.
The Boss! Immunity Bar features crunchy wafer layers woven with a creamy filling and covered in chocolatey goodness, the company said.
Available in four flavors — peanut butter cup, chocolate mint brownie, caramel macchiato and maple French toast — the non-GMO bars contain probiotic ingredients to help support immune health and protein utilization, as well as 2 g of sugar, and have no artificial flavors or sweeteners.
Currently, Lenny & Larry’s the Boss! Immunity Bars are available online in a four-count box that retails for $7.99.
The National Community Pharmacists Association and the American Pharmacists Association announced today that they have voluntarily dismissed a lawsuit dating back to the previous administration. The two groups were the lead plaintiffs in the federal case against the secretary of Health and Human Services.
“We’ve been fighting in Congress for years to end retroactive pharmacy DIR fees and lower prescription costs for seniors and protect small business pharmacies. We’ve been working with HHS and CMS for years on a regulatory solution, and more than a year ago we strategically filed a lawsuit in case the other two roads were blocked,” said NCPA CEO Douglas Hoey. “We are cautiously optimistic that the new Part D rule satisfies the goals we had for the lawsuit.”
We’ll be watching closely to see how the rule is implemented and whether PBMs comply or try to game the system. If they don’t, we reserve the right to return to court,” he said.
“Shutting down our legal challenge doesn’t end our fight for justice for pharmacies from unfair PBM practices,” said APhA interim executive vice president and CEO Ilisa Bernstein. “We know the final rule benefits patients and increases transparency, but time will tell if it also benefits our nation’s pharmacists.”
NCPA filed the lawsuit in the closing days of the Trump administration after multiple administrations had failed to address retroactive pharmacy DIR fees. The group was joined shortly thereafter by APhA and several other plaintiffs.
Pharmacy DIR, which stands for Direct and Indirect Remunerations, is a catchall term used to describe various price concessions required from pharmacies by PBMs in order to participate in the Medicare Part D program. Those concessions have grown by more than 107,000% since 2010, according to CMS, and wind up inflating seniors’ share of their prescription drug costs. They also are assessed retroactively, often months after the transaction, making it impossible for pharmacies to keep up with and predict the cost of these transactions. The litigation took aim at the retroactive nature of these fees, which NCPA and APhA hope will end due to the recent changes in CMS policy.
Mamitas drops summer-inspired tequila hard seltzers
Mamitas Hard Seltzer is getting ready for summer by launching two new flavors of its beverages, which are made with tequila.
A play on popular cocktails, the brand presents Spicy Marg and Tequila Sunrise drinks, which join the previously launched Paloma, lime, mango and pineapple varieties.
The Spicy Marg has a margarita body with a light cayenne kick and Tequila Sunrise tastes like a lighter-flavored version of the classic cocktail.
Made with 100% real tequila, each naturally gluten-free drink contains less than 1.5 g of sugar, 5% ABV and 95 calories, the company said.
Mamitas Hard Seltzer is available in an eight-count variety pack that retails from $17.99 to $21.99, a four-count pack from $9.99 to $12.99 and single 12-oz. cans that retail from $5 to $7. The classic flavors can be found on Drizly, as well as at Target, Walmart, Kroger and Publix among other retailers.
The company has been honored with a Distribution Industry Award for Notable Achievement in Healthcare for Best Overall Branded Pharmaceutical Product Manufacturer with less than $300 million in sales by the Healthcare Distribution Alliance, or HDA.
"Upsher-Smith is committed to upholding our reputation as a trusted healthcare partner. Delivering peace of mind for our customers by offering the best in supply and pharmaceutical manufacturing excellence is at the forefront of all that we do," said Rich Fisher, president and COO of Upsher-Smith. "This marks the 13th DIANA award for Upsher-Smith, and we are especially proud of the ongoing confidence that distributors have in our product quality and reliable supply. This customer confidence fuels our team to bring even more products to our trading partners in the years ahead."
Upsher-Smith will soon expand upon its long-standing, award-winning relationships with distributors with the opening of its new, 270,000-sq-ft., state-of-the-art manufacturing facility in Maple Grove, Minn. The new site will have up-to-the-minute serialization and packaging capabilities and has capacity and capabilities that could support contract manufacturing for third parties.
The HDA presented the awards to outstanding pharmaceutical and consumer product manufacturers at its 2022 Business and Leadership Conference in Orlando on June 6, 2022.
Since 1959, the DIANA Awards have been presented to pharmaceutical and consumer product manufacturers that set the standard for excellence in developing innovative new product introductions and promotions, fostering exceptional trading partner relationships, advancing trade relations and creating business practices that benefit the entire healthcare supply chain.
DIANA finalists and winners for Best Overall Company are chosen by HDA distributor members who judge companies based on several criteria including knowledgeable salespeople, high-level customer service, demonstrated flexibility and creativity in marketing and incorporation of new technologies to ensure product safety and security.
Upsher-Smith is included among a distinguished group of present and past recipients who serve as models for leadership and innovation in the healthcare marketplace.
The National Community Pharmacists Association is hailing a move by the Federal Trade Commission to proceed with a 6(b) study of pharmacy benefit managers and anti-competitive business practices.
After the commission in February split 2-2 on a proposal to launch a formal study into PBMs, FTC chair Lina Khan pledged to call for another vote on the issue.
“PBMs behave like monopolies. Their secretive, anticompetitive practices increase prescription drug prices, limit consumer choice and stymie competition. They’ve escaped serious scrutiny for far too long, but this study will bring their dirty laundry out into the open,” said NCPA CEO Doug Hoey.
The vote comes after Alvaro Bedoya, who was sworn in as commissioner in May, joined Khan and all commissioners in voting to support the investigation. This will make the six largest PBMs (CVS Caremark; Express Scripts; OptumRx; Humana; Prime Therapeutics; and MedImpact Healthcare Systems) hand over information on PBM business practices, including fees and clawbacks charged to unaffiliated pharmacies, patient-steering, audits of independent pharmacies, reimbursement and more, the organization said.
“NCPA has repeatedly called on the FTC to scrutinize PBM practices and thousands of community pharmacy owners and their allies have shared with the FTC their examples of the impact health insurer-owned PBMs have on consumer costs and access to prescription drugs contributing to the FTC decision to do the 6(b) study. These examples have made a difference. We’re grateful to chair Khan and the commissioners for considering these concerns and approving this study, which we hope will result in meaningful reforms to merger and acquisition reviews and, of course, to the insurer-PBMs themselves.,” said Hoey.