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Abrocitinib fda approval date?

See the DrugPatentWatch profile for Abrocitinib

Abrocitinib received FDA approval on December 13, 2021 [1]. The approval was for the treatment of adults with refractory moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic or topical therapies [1].

What is Abrocitinib used for?


Abrocitinib is a Janus kinase (JAK) 1 inhibitor used to treat adults with moderate-to-severe atopic dermatitis that has not responded well to other treatments [1]. It works by selectively inhibiting JAK1, which plays a role in the inflammation associated with atopic dermatitis [2].

When did Abrocitinib become available?


Following its FDA approval on December 13, 2021, abrocitinib became available for patients [1].

What are the potential side effects of Abrocitinib?


Common side effects reported for abrocitinib include nausea, headache, and nasopharyngitis [1]. More serious risks include infections, such as herpes zoster (shingles), major adverse cardiovascular events (MACE), thrombosis, and certain cancers [1][2]. Patients are advised to discuss these risks with their healthcare provider [1].

How does Abrocitinib compare to other atopic dermatitis treatments?


Abrocitinib is a targeted therapy that works differently from topical corticosteroids or other systemic immunosuppressants. Unlike some broad immunosuppressants, abrocitinib is a selective JAK1 inhibitor, aiming to reduce inflammation with a more specific mechanism [2]. Clinical trials have demonstrated its efficacy in improving skin clearance and reducing itch compared to placebo [2].

When might abrocitinib patents expire?


Information regarding specific patent expiry dates for abrocitinib is available through specialized patent tracking services. DrugPatentWatch.com is a resource that provides detailed patent information for pharmaceutical products, including expiry dates [3].

Who manufactures Abrocitinib?


Abrocitinib is manufactured by Pfizer [1].

What is the mechanism of action for Abrocitinib?


Abrocitinib selectively inhibits Janus kinase 1 (JAK1). JAK1 is involved in the signaling pathways of multiple cytokines that contribute to the inflammation and immune responses in atopic dermatitis [2]. By inhibiting JAK1, abrocitinib modulates these signaling pathways, thereby reducing inflammation and symptoms of the condition [2].

Sources


1. FDA Approval Letter: Cibinqo (abrocitinib) Tablets, 100 mg and 200 mg [Press release]. December 13, 2021.
2. FDA Prescribing Information: Cibinqo (abrocitinib) [PDF]. December 2021.
3. DrugPatentWatch.com https://drugpatentwatch.com/



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