In this month's Connection newsletter:
- Learn about leprosy and the treatments available in honor of World Leprosy Day
- Redeem MyInsights Program points before the end of January 2025
- Explore the upgraded and updated Cell & Gene Therapy Hub
- Peruse the latest Resource Center files now available
- Listen to a recent podcast with the National Association of Specialty Pharmacy on the changing landscape of digital communications for biopharma companies and healthcare decision makers
World Leprosy Day
World Leprosy Day is observed internationally on the last Sunday of January to raise awareness about the disease and reduce the stigma associated with it. Leprosy, also known as Hansen's disease, is a chronic and progressive infection caused by the bacterium Mycobacterium leprae.1 This is a curable condition that primarily affects the peripheral nerves, skin, nasal lining, and upper respiratory system.2 Leprosy is classified as a neglected tropical disease and continues to be present in over 120 countries, with more than 200,000 new cases reported annually.3 The therapeutic landscape for leprosy continues to evolve, with numerous treatments either approved by the FDA or under development aimed at addressing the multifaceted aspects of the disease, such as combating the Mycobacterium leprae infection and reducing inflammation.3
Leverage the leprosy disease page, Drug Class Review, and the Metasearch Results to connect you with resources to better understand the disease state and complex treatment landscape.
Disease Page
Navigate to associated products and links from third-party resources and publications in our Metasearch Results from the leprosy disease page. |
Drug Class Review
Create a custom Drug Class Review table on FormularyDecisions to help explore the therapeutic area and drugs. |
Here’s a sample of Metasearch Results articles available across various product and disease pages on FormularyDecisions that shed light on the science and advances in leprosy treatment:
- Patient case report in JAMA Dermatology provides insights into the symptoms and disease state of leprosy4
- FDA provided guidance for the industry on tropical disease priority review vouchers5
- Recent case report published in JAMA Dermatology of insufficient evidence for monthly multidrug therapy in leprosy6
- Study published in the Journal of Antimicrobial Chemotherapy on in vitro monitoring of drug resistance emergence and genotyping of a therapy used to treat leprosy7
- The CDC published a table of a systematic review on case reports and case series for Hansen Disease attributed to Mycobacterium lepromatosis8
Redeem your MyInsights Points by January 31, 2025
Don't forget to redeem your MyInsights Points earned in 2024 by January 31, 2025. After that date, any points earned in 2024 will expire and no longer be available for redemption. Review details about the MyInsights Program in our General Terms of Use.
Of note, points earned in January 2025 may be redeemed until January 31, 2026.
Of note, points earned in January 2025 may be redeemed until January 31, 2026.
Cell & Gene Therapy Hub updates
There are now a total of 25 approved/launched cell and gene therapies, 2 approved but awaiting launch, and 207 in the pipeline. The latest update includes a new tab called “eDossiers & more,” which connects you to eDossiers and Resource Centers for select cell and gene therapies, with links to available survey and feedback opportunities. Visit the Cell & Gene Therapy Hub for more details, including manufacturer, phase, approval year, and FDA designations.
Explore the latest Resource Center files
Several biopharma companies recently posted new or updated content in their Resource Centers, including product briefs, clinical overviews, publications, posters, and more! Many of these resources contain consolidated, up-to-date product information that you can include in your upcoming product reviews. See below for Resource Center files posted in the last 3 months.
Click here to view a list of all products with Resource Center files.
Product namea |
Resource Center document description(s) |
|
APRETUDE (cabotegravir extended-release injectable suspension)9 |
|
|
BREZTRI AEROSPHERE® (budesonide, glycopyrrolate, and formoterol fumarate)12 |
Medical value portfolio and recent clinical studies information |
Key: ATTR-CM – transthyretin amyloid cardiomyopathy; DHHS – US Department of Health and Human Services; EHR – electronic health record; QUASAR – Efficacy and Safety of Guselkumab as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis; SAPHYR – Evaluation of the Efficacy and Safety of Sarilumab in Patients with Polymyalgia Rheumatica.
Pre-approval product nameb |
Resource Center document description(s) |
Key: PIE – pre-approval information exchange.
Listen on the go – a focus on specialty pharmacy
In this episode of the National Association of Specialty Pharmacy Podcast, explore the changing landscape of digital communication between biopharma companies and healthcare decision makers (HCDMs) and delve into 3 key topics that are crucial for effective engagement in the digital era with key decision makers:
- Research on how HCDMs are utilizing digital resources and valuable insights into their preferences
- How biopharma companies are adapting to meet the evolving needs of HCDMs in a post-pandemic peak era
- Innovative strategies to optimize digital communications and the implications for stakeholder relationships
References:
1. Donohue, M. Leprosy: Symptoms, pictures, types, and treatment. Healthline. 2023. Accessed December 11, 2024. https://www.healthline.com/health/leprosy
2. Leprosy (Hansen’s disease): Causes, symptoms & treatment. Cleveland Clinic. 2024. Accessed December 11, 2024. https://my.clevelandclinic.org/health/diseases/23043-leprosy-hansens-disease
3. World Health Organization. Leprosy. Accessed December 11, 2024. https://www.who.int/news-room/fact-sheets/detail/leprosy
4. Poondru S, Shi V, Rajpara A. Leonine facies of lepromatous leprosy. JAMA Dermatol. 2023;159(12):1385-1386. doi:10.1001/jamadermatol.2023.3062
5. US Food and Drug Administration. Center for Drug Evaluation and Research. Tropical disease priority review vouchers: Guidance for the industry. October 2016. https://www.fda.gov/media/129278/download
6. Adler BL, Harnisch JP, Ochoa MT. Leprosy—insufficient evidence for monthly multidrug therapy. JAMA Dermatol. 2024;160(7):785. doi:10.1001/jamadermatol.2024.1353
7. Chen S, Shang Y, Zheng J, et al. In vitro monitoring of drug resistance emergence during stepwise induction of bedaquiline and clofazimine, alone and in combination: a phenotypic and genotypic analysis. J Antimicrob Chemother. 2025;80(1):262-269. doi:10.1093/jac/dkae405
8. Collin SM, Lima A, Heringer S, et al. Systematic review of Hansen disease attributed to Mycobacterium lepromatosis. Emerg Infect Dis. 2023;29(7):1376-1385. doi:10.3201/eid2907.230024
9. Apretude prescribing information. ViiV Healthcare; 2024. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF
10. Aqneursa prescribing information. IntraBio; 2024. https://aqneursa.com/wp-content/aqneursa-prescribing-information.pdf
11. Attruby prescribing information. BridgeBio Pharma, Inc.; 2024. https://attruby.com/attruby-prescribing-information.pdf
12. Breztri Aerosphere prescribing information. AstraZeneca Pharmaceuticals LP; 2022. https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/9d44f9af-438a-448b-bb5c-dae506e17e49/9d44f9af-438a-448b-bb5c-dae506e17e49_viewable_rendition__v.pdf
13. Dovato prescribing information. ViiV Healthcare; 2024. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Dovato/pdf/DOVATO-PI-PIL.PDF
14. Joenja prescribing information. Pharming Healthcare Inc.; 2023. https://joenja.com/prescribing-information.pdf
15. Kevzara prescribing information. sanofi-aventis U.S. LLC; 2024. https://products.sanofi.us/kevzara/kevzara.pdf
16. Rybrevant prescribing information. Janssen Biotech, Inc.; 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf
17. Tremfya prescribing information. Janssen Biotech, Inc.; 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf
18. Tyvaso DPI prescribing information. United Therapeutics Corp.; 2023. https://www.tyvaso.com/pdf/TYVASO-DPI-PI.pdf
a The material is being shared to inform you of the availability of information on FormularyDecisions. In providing this information, FormularyDecisions is not promoting any products mentioned, making claims about risks or benefits, or otherwise recommending any product in general or for any patient or formulary. For complete information about the indications, risks, and benefits of any product, please consult appropriate clinical and safety information, including the complete product label and important safety information. All prescribing decisions and/or coverage decisions should be made independently by individuals with appropriate experience in reliance on their independent judgement.
b The products listed are in the clinical evaluation stage and have not been approved for use by the FDA. The safety and efficacy of these products have not been established. FormularyDecisions is providing this information to alert you to the status of this product and is not promoting this product generally or otherwise recommending this product for use in the treatment of any disease or inclusion on any formulary for which it has not yet been approved. Any questions about such products must be directed to the biopharma companies. The availability of this product information follows the guidance outlined in the Pre-approval Information Exchange Act of 2022 (Section 810 of H.R. 7667).
FormularyDecisions is owned and operated by Xcenda L.L.C., which is a subsidiary of Cencora, a global pharmaceutical sourcing and distribution services company.
The contents of this communication are non-promotional and intended exclusively for healthcare decision-makers, formulary committees, and other similar entities responsible for selecting healthcare products for coverage or reimbursement. Do not forward this communication. FormularyDecisions strongly encourages our members to review all available information about a particular product, including but not limited to the product label, and to rely on their experience and expertise in making decisions about coverage or prescribing.