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Leo Pharma

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LEO Pharma Announces U.S. FDA Acceptance of Biologics License Application for Tralokinumab for Moderate-to-Severe Atopic Dermatitis

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: LP0162

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 09, 2020

Details:

Submission includes data from pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating safety and efficacy of tralokinumab.

Leo Pharma

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LEO Pharma Announces European Medicines Agency Acceptance of Marketing Authorization Application for tralokinumab to Treat Atopic Dermatitis

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

Details:

The MAA is based on data from the pivotal ECZTRA 1, 2 and 3 Phase 3 studies evaluating the efficacy and safety of tralokinumab.

Leo Pharma

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LEO Pharma Presents Phase 3 Data in Atopic Dermatitis and Plaque Psoriasis at the American Academy of Dermatology Virtual Meeting

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2020

Details:

Data include pivotal efficacy and safety clinical trials of tralokinumab monotherapy and tralokinumab with concomitant topical corticosteroid use in adult patients with moderate-to-severe atopic dermatitis.

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Leo Pharma

LEO Pharma Announces U.S. FDA Acceptance of Biologics License Application for Tralokinumab for Moderate-to-Severe Atopic Dermatitis

Leo Pharma

LEO Pharma Announces European Medicines Agency Acceptance of Marketing Authorization Application for tralokinumab to Treat Atopic Dermatitis

Leo Pharma

LEO Pharma Presents Phase 3 Data in Atopic Dermatitis and Plaque Psoriasis at the American Academy of Dermatology Virtual Meeting