2024 Drug & Device Approvals in Review

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January 5, 2024
FDA approves berdazimer gel, 10.3% (Zelsuvmi) for the treatment of molluscum contagiosum in patients 1 year and older¹

January 16, 2024
Dupilumab (Dupixent) label updated to include uncontrolled atopic dermatitis on hands and feet of patients 12 years and older²

January 17, 2024
DermaSensor handheld device cleared for the detection of melanoma, basal cell carcinoma, and squamous cell carcinoma³

February 16, 2024
Lifileucel (Amtagvi) receives accelerated approval for advanced melanoma treatment⁴

February 23, 2024
Adalimumab-ryvk (Simlandi) granted approval as the first interchangeable Humira biosimilar for some uses⁵

February 28, 2024
LUT014 B-Raf inhibitor receives orphan drug designation for the treatment of EGFRI-induced acneiform rash⁶

March 5, 2024
Juvéderm Voluma XC becomes the first and only hyaluronic acid dermal filler for use in moderate to severe temple hollowing7

March 19, 2024
Spesolimab-sbzo (Spevigo) injection for generalized pustular psoriasis receives extended approval⁸

April 16, 2024
Stelara biosimilar Selarsdi (ustekinumab-aekn) approved for patients with psoriasis and psoriatic arthritis⁹

May 1, 2024
High-concentration, citrate-free version of adalimumab-adbm (Cyltezo) approved for use in various indications¹⁰

June 10, 2024
Tirbanibulin (Klisyri) approved for actinic keratosis over larger areas of the face and scalp¹¹

June 13, 2024
Tralokinumab-ldrm single-dose 300-mg autoinjector (Adbry) approved for adults with moderate to severe atopic dermatitis¹²

June 20, 2024
Sofpironium (Sofdra) becomes the first and only chemical entity for primary axillary hyperhidrosis in patients 9 years and older¹³

June 24, 2024
RhodoLED XL Lamp red light source and aminolevulinic acid hydrochloride (Ameluz) topical gel, 10% combination approved for mild to moderate actinic keratosis¹⁴

July 9, 2024
Roflumilast (Zoryve) cream 0.15% approved for patients 6 years and older with atopic dermatitis¹⁵

July 26, 2024
Oral JAK inhibitor deuruxolitinib (Leqselvi) cleared for the treatment of severe alopecia areata in adults¹⁶

August 13, 2024
Nemolizumab (Nemluvio) cleared as a prefilled pen for subcutaneous injection for the treatment of prurigo nodularis in adults¹⁷

August 14, 2024
Candela’s Matrix multi-application radiofrequency platform approved for the treatment of facial wrinkles¹⁸

September 13, 2024
Lebrikizumab-lbkz (Ebglyss) approved for patients 12 years and older with moderate to severe atopic dermatitis¹⁹

September 23, 2024
UCB’s bimekizumab-bkzx (Bimzelx) approved for adults with active psoriatic arthritis²⁰

September 23, 2024
New drug application accepted for delgocitinib cream for the treatment of chronic hand eczema²¹

September 27, 2024
Ustekinumab-aauzbiosimilar (Otulfi) approved for moderate to severe plaque psoriasis and active psoriatic arthritis²²

October 15, 2024
Accure Laser System cleared for the long-term treatment of mild to severe inflammatory acne vulgaris²³

November 4, 2024
Minocycline hydrochloride extended release capsules, 40 mg (Emrosi) approved for the treatment of adult rosacea²⁴

References

1. US Food and Drug Administration approves Zelsuvmi as a first-in-class medication for the treatment of molluscum contagiosum. News release. Ligand Pharmaceuticals. January 5, 2024. Accessed November 7, 2024. https://investor.ligand.com/news-and-events/press-releases/news-details/2024/U.S.-Food-and-Drug-Administration-Approves-ZELSUVMI-as-a-First-in-Class-Medication-for-the-Treatment-of-Molluscum-Contagiosum/default.aspx

2. Dupixent (dupilumab) U.S. label updated with data further supporting use in atopic dermatitis with moderate-to-severe hand and foot involvement. Regeneron Pharmaceuticals. January 16, 2024. Accessed November 7, 2024. https://www.globenewswire.com/news-release/2024/01/16/2809695/0/en/Dupixent-dupilumab-U-S-Label-Updated-with-Data-Further-Supporting-Use-in-Atopic-Dermatitis-with-Moderate-to-Severe-Hand-and-Foot-Involvement.html

3. FDA clearance granted for first AI-powered medical device to detect all three common skin cancers (melanoma, basal cell carcinoma and squamous cell carcinoma). News release. DermaSensor. January 17, 2024. Accessed November 7, 2024. https://www.dermasensor.com/fda-clearance-granted-for-first-ai-powered-medical-device-to-detect-all-three-common-skin-cancers-melanoma-basal-cell-carcinoma-and-squamous-cell-carcinoma/

4. Iovance’sAmtagvi (lifileucel) receives U.S. FDA accelerated approval for advanced melanoma. News release. Iovance Biotherapeutics. February 16, 2024. Accessed November 7, 2024. https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvitm-lifileucel-receives-us-fda-accelerated

5. Alvotech and Teva announce U.S. approval of Simlandi (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira. News release. Alvotech. February 23, 2024. Accessed November 7, 2024. https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-teva-announce-us-approval-simlandir-adalimumab-ryvk

6. Lutris Pharma receives FDA orphan drug designation for LUT014 for the treatment of EGFRI-induced acneiform rash. News release. Lutris Pharma. February 28, 2024. Accessed November 7, 2024. https://prnmedia.prnewswire.com/news-releases/lutris-pharma-receives-fda-orphan-drug-designation-for-lut014-for-the-treatment-of-egfri-induced-acneiform-rash-302073519.html

7. Juvéderm Voluma XC for temple hollows receives U.S. FDA approval. News release. AbbVie. March 5, 2024. Accessed November 7, 2024. https://news.abbvie.com/2024-03-05-JUVEDERM-R-VOLUMA-R-XC-For-Temple-Hollows-Receives-U-S-FDA-Approval#:~:text=%22This%20is%20the%20first%20U.S.,real%20unmet%20need%20for%20patients.%22

8. Spevigo approved for expanded indications in China and the US. News release. Boehringer Ingelheim. March 19, 2024. Accessed November 7, 2024. https://www.boehringer-ingelheim.com/us/spevigo-approved-expanded-indications-china-and-us

9. Alvotech and Teva announce U.S. FDA approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab). News release. Teva. April 16, 2024. Accessed November 7, 2024. https://www.tevapharm.com/news-and-media/latest-news/alvotech-and-teva-announce-u.s.-fda-approval-of-selarsdi-ustekinumab-aekn-biosimilar-to-stelara-ust

10. US FDA approves Boehringer Ingelheim’s high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm). News release. Boehringer Ingelheim. May 1, 2024. Accessed November 7, 2024. https://www.prnewswire.com/news-releases/us-fda-approves-high-concentration-citrate-free-formulation-of-cyltezo-adalimumab-adbm-injection-boehringer-ingelheims-interchangeable-biosimilar-to-humira-302132457.html

11. FDA approves Almirall’s Klisyri (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2. News release. Almirall. June 10, 2024. Accessed November 7, 2024. https://www.almirall.com/newsroom/news/fda-approves-almirall-s-klisyri-tirbanibulin-for-the-treatment-of-actinic-keratosis-on-expanded-area-of-face-or-scalp-up-to-100-cm2

12. FDA approves Adbry (tralokinumab-ldrm) autoinjector for the treatment of adults with moderate-to-severe atopic dermatitis (AD). News release. Leo Pharma. June 13, 2024. Accessed November 7, 2024. https://www.businesswire.com/news/home/20240613529061/en/FDA-Approves-Adbry%C2%AE-tralokinumab-ldrm-Autoinjector-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Atopic-Dermatitis-AD

13. FDA approval of Sofdra - the first new drug for primary axillary hyperhidrosis. News release. Botanix Pharmaceuticals. June 20, 2024. Accessed November 7, 2024. https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299

14. Biofrontera announces the launch of a new, FDA-approved red light source, the RhodoLED XL lamp. News release. BioSpace. June 24, 2024. Accessed November 7, 2024. https://www.biospace.com/article/releases/biofrontera-announces-the-launch-of-a-new-fda-approved-red-light-source-the-rhodoled-xl-lamp/

15. FDA approves Arcutis’ Zoryve (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age. News release. Arcutis Biotherapeutics. July 9, 2024. Accessed November 7, 2024. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-015-treatment

16. U.S. FDA approves Leqselvi (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata. News release. Sun Pharma. July 26, 2024. Accessed November 7, 2024. https://www.prnewswire.com/news-releases/us-fda—approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207222.html?tc=eml_cleartime

17. Galderma receives U.S. FDA approval for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis. News release. Galderma. August 13, 2024. Accessed November 7, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo

18. Candela announces FDA-clearance of new indication for Matrix multi-application radiofrequency skin platform. News release. Candela. August 14, 2024. Accessed November 7, 2024. https://www.prnewswire.com/news-releases/candela-announces-fda-clearance-of-new-indication-for-matrix-multi-application-radiofrequency-skin-platform-302221615.html

19. FDA approves Lilly’s Ebglyss (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. News release. Lilly. September 13, 2024. Accessed November 7, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and

20. UCB announces U.S. FDA approvals for Bimzelx (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. News release. UCB. September 23, 2024. Accessed November 7, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-us-fda-approvals-for-bimzelxr-bimekizumab-bkzx-for-the-treatment-of-psoriatic-arthritis-non-radiographic-axial-spondyloarthritis-and-ankylosing-spondylitis

21. FDA accepts Leo Pharma’s filing of delgocitinib cream new drug application for the treatment of chronic hand eczema. News release. Leo Pharma. September 23, 2024. Accessed November 7, 2024. https://www.businesswire.com/news/home/20240923600460/en/FDA-Accepts-LEO-Pharma%E2%80%99s-Filing-of-Delgocitinib-Cream-New-Drug-Application-for-the-Treatment-of-Chronic-Hand-Eczema

22. FDA grants approval for Stelara biosimilar (ustekinumab-aauz). Formycon. September 27, 2024. Accessed November 7, 2024. https://www.formycon.com/en/blog/press-release/fda-grants-approval-for-stelara-biosimilar-fyb202-otulfitm-ustekinumab-aauz/

23. Accure Acne announces new FDA clearance for the long-term treatment of acne. Accure Acne. October 15, 2024. Accessed November 7, 2024. https://www.prnewswire.com/apac/news-releases/accure-acne-announces-new-fda-clearance-for-the-long-term-treatment-of-acne-302276293.html

24. Journey Medical Corporation Announces U.S. FDA approval of Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for the treatment of rosacea. Journey Medical Corporation. November 4, 2024. Accessed November 7, 2024. https://www.globenewswire.com/news-release/2024/11/04/2973917/0/en/Journey-Medical-Corporation-Announces-U-S-FDA-Approval-of-Emrosi-Minocycline-Hydrochloride-Extended-Release-Capsules-40-mg-for-the-Treatment-of-Rosacea.html