August 1, 2023

Vyalev a continuous subcutaneousinfusion for Parkinson’s disease is now launched in Japan – AbbVie

AbbVie has launched Vyalev (foslevodopa + foscarbidopa), a continuous subcutaneous infusion for Parkinson’s disease, in Japan on July 26. This is the first Parkinson’s drug in the country that can be continuously infused for 24 hours without requiring surgery. In Japan, Vyalev was approved in December 2022 for the improvement of wearing-off symptoms in Parkinson’s inadequately controlled with existing pharmacotherapies […]

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June 29, 2023

Positive CHMP opinion for atogepant for the preventive treatment of adults with migraine – AbbVie

AbbVie announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral calcitonin gene-related peptide (CGRP) […]

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January 30, 2022

AbbVie provides update on Rinvoq for the treatment of rheumatoid arthritis in the U.S

AbbVie announced an update to the U.S. Prescribing Information and Medication Guide for Rinvoq (upadacitinib) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). This update follows a Drug Safety Communication (DSC) issued on 1 September, 2021 by the FDA following its final review of the post-marketing study, ORAL Surveillance, evaluating Xeljanz (tofacitinib) in patients with RA. […]

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November 2, 2021

FDA approves Vuity for presbyopia – Allergan / AbbVie

Allergan announced the FDA approval of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. Vuity is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population. The FDA approval of Vuity […]

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October 19, 2021

FDA approves Qulipta for prevention of migraine – AbbVie

The FDA has approved Qulipta (atogepant tablets), from AbbVie, for the preventive treatment of episodic migraine in adults. The approval of Qulipta was based on findings from the Phase III ADVANCE study, a Phase II/III efficacy, safety, and tolerability study, and a Phase III long-term safety study. In the pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial, 910 […]

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June 3, 2021

European Commission approval for Venclyxto + a hypomethylating agent for newly diagnosed acute myeloid leukemia – AbbVie

AbbVie announced that the European Commission (EC) has approved Venclyxto (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway. “Venclyxto has […]

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