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J&J and Roche named to Clarivate’s Top 100 Global Innovators list

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

AbbVie files supplemental New Drug Application with FDA for cariprazine

AbbVie (NYSE: ABBV) has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar)for major depressive disorder (MDD).

FDA first approved cariprazine for schizophrenia and bipolar disorder in 2015. Current indications of the drug cover the acute treatment of manic or mixed episodes related to bipolar I disorder and depressive episodes associated with bipolar I disorder.

In its recent sNDA, AbbVie is attempting to secure approval of the drug as an adjunctive treatment with MDD who receive ongoing antidepressants.

Antidepressants are a cornerstone of treating depression, although experts are divided on the efficacy of antidepressants in general. One study published on InformedHealth.org found that antidepressants at large are roughly 20% more effective than placebo in treating depression.

In the submission, AbbVie included data on cariprazine recipients showing clinical improvements based on the Montgomery-Åsberg Depression Ratin…

FDA approves generic for dry-eye treatment Restasis

Viatris (NSDQ:VTRS) has received FDA approval for the first generic of Restasis (cyclosporine ophthalmic emulsion) eye drops.

FDA first approved the drug, which was developed by Allergan, in 2003.

Now marketed by AbbVie (NYSE:ABBV), Restasis sales are on the order of $1.2 billion annually.

AbbVie recently noted in its projections for 2022 that it expected to maintain U.S. exclusivity of the drug.

Although no longer covered by patent protection, “the complex nature of the product” delayed the launch of a generic, wrote Truist analyst Gregory D. Fraser in a briefing note.

Generic Restasis revenue could be “a material sales contributor for VTRS given the size of the market and potential for limited competition,” Fraser said.

To attempt to discourage generic competition tied to Restasis, Allergan transferred six patents related to the drug to the St. Regis tribe of the Mohawk people in 2017. Allergan made an upfront payment of $13.75 mi…

FDA approves second indication of AbbVie’s Skyrizi for adults with active psoriatic arthritis

FDA first approved AbbVie’s (NYSE:ABBV) interleukin-23 inhibitor Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis in 2019. Now, the agency has extended the approval to include adults with active psoriatic arthritis (PsA), which affects almost one out of three people with psoriasis.

To win the new indication, AbbVie provided data from the KEEPsAKE-1 and KEEPsAKE-2 pivotal studies. Those studies tested Skyrizi in adults with active PsA, including refractory patients.

In the placebo-controlled KEEPsAKE trials, Skyrizi met the primary endpoint of ACR20 at week 24. ACR20 is a composite measure from the American College of Rheumatology that refers to 20% improvement across several variables, including swollen, tender and painful joints.

“In the pivotal KEEPsAKE trials, Skyrizi demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis,” said Dr. Alan J. Kivitz, KEEPsAKE clinical…

AbbVie files Rinvoq application for non-radiographic axial spondyloarthritis in U.S. and Europe

AbbVie (NYSE:ABBV) has submitted applications asking for approval of upadacitinib (Rinvoq) from the FDA and the European Medicines Agency (EMA) to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA). If approved, Rinvoq would be indicated for nr-axSpA patients with objective signs of inflammation with an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).

The Janus kinase (JAK) inhibitor Rinvoq recently won FDA approval for an active psoriatic arthritis indication.

FDA first approved Rinvoq for moderate to severe rheumatoid arthritis in 2019.

For the potential nr-axSpA indication, AbbVie filed positive data from the Phase 3 SELECT-AXIS 2 study.

“Axial spondyloarthritis is a chronic inflammatory disease affecting the spine and can cause patients, who tend to be younger adults living active lives, to suffer from debilitating pain and significantly decrease their quality of life,” said Dr. Thomas…

FDA approves first eye drop for presbyopia

AbbVie (NYSE:ABBV) subsidiary Allergan has received FDA approval for Vuity (pilocarpine HCl ophthalmic solution), a novel eye drop for treating presbyopia. This common age-related condition leads millions of middle-aged people to acquire reading glasses.

Vuity is a once-daily prescription eye drop.

Presbyopia, or age-related blurry near vision, can be diagnosed through a basic eye exam by an eye doctor (optometrist or ophthalmologist) and is a common and progressive eye condition that affects 128 million Americans, or nearly half of the U.S. adult population.

“We are pleased to be able to bring this first-of-its-kind treatment to market sooner than expected for the millions of Americans with presbyopia who may benefit from it,” said Jag Dosanjh, senior vice president of medical therapeutics, Allergan, in a press release.

Vuity uses Allergan’s proprietary pHast technology, which facilitates the eye drop’s ability to adapt to the physiol…

Rinvoq meets primary and important secondary endpoints in Phase 3 Crohn’s disease study

AbbVie (NYSE:ABBV) has released positive top-line results from U-EXCEED, which showed that Rinvoq (upadacitinib) hit both primary endpoints of clinical remission and endoscopic response at week 12 of a Phase 3 induction study focused on patients with Crohn’s disease.

Upadacitinib is a selective and reversible JAK inhibitor first FDA approved in 2019 for treating adults with moderate to severe rheumatoid arthritis. It is now also marketed for ankylosing spondylitis and psoriatic arthritis.

The U-EXCEED is the first of two Phase 3 induction studies testing upadacitinib in adults with moderate to severe Crohn’s disease.

The multicenter study was randomized, double-blind and placebo-controlled.

Image courtesy of AbbVie

The patients in the U-EXCEED enrolled patients with Crohn’s disease who had a poor response or were intolerant to biologics. In the patient pool, more than 60% had failed two …

AbbVie, University of Chicago lengthen oncology research partnership until 2025

AbbVie (NYSE: ABBV) has extended an agreement with the University of Chicago related to collaborative preclinical oncology research.

The North Chicago, Illinois–based company and the university are working together on research involving biomarkers and therapeutic applications related to existing AbbVie programs.

In the past, the organizations have also explored new drug delivery methods to improve the immune system’s ability to fight tumors. Their partnership has also focused on testing 3D screening methodologies for selecting promising therapeutic molecules.

Under the terms of the agreement, AbbVie can exclusively license some University of Chicago discoveries resulting from the collaboration.

“Our oncology collaboration with the University of Chicago enables us to combine our expertise in understanding the underlying biology in key areas of interest, such as immuno-oncology, oncogenic pathways, and biomarkers of drug sensitivity or disease,” Ste…

Regenxbio inks deal with AbbVie to pursue development of RGX-314

Regenxbio (NSDQ:RGNX) has closed a license agreement with AbbVie (NYSE:ABBV) to develop RGX-314, a vascular endothelial growth factor inhibitor.

The drug has been the focus of Phase 2 and Phase 3 trials exploring its potential in wet age-related macular degeneration (AMD) and diabetic retinopathy.

AbbVie will make an upfront payment to Regenxbio of $370 million and could pay an additional $1.38 billion if the drug candidate meets proposed development, regulatory and commercial milestones.

In the agreement, Regenxbio will focus on overseeing the completion of ongoing trials related to the RGX-314. The two companies will partner and split the cost of additional studies related to the drug candidate.

The two companies intend to perform an additional pivotal trial testing subretinal delivery to treat wet AMD and future trials.

AbbVie plans on leading clinical development and commercialization of the drug.

In October, Regenxbio released p…

AbbVie shares new Rinvoq data involving patients with psoriatic arthritis

Abbvie’s JAK inhibitor Rinvoq (upadacitinib) beat out placebo at week 24 in posthoc analyses of two Phase 3 studies focused on people with active psoriatic arthritis. In particular, the drug led to a superior clinical response related to axial involvement, which occurs in a substantial portion of people with psoriatic arthritis.

Sharing the data at the American College of Rheumatology (ACR) Convergence 2021 conference, AbbVie says the data underscore the drug’s potential for many people with psoriatic arthritis. “These data further add to the body of evidence that support the potential of upadacitinib to be an important treatment option that helps reduce the impact of the many disease manifestations of psoriatic arthritis,” said Dr. Thomas Hudson, senior vice president, research and development, chief scientific officer of AbbVie, in a press release.

Last year, Rinvoq generated $731 million in net revenues globally.

FDA approved Rinvoq in 2019 to treat m…

AbbVie beats The Street in Q3, raises guidance

AbbVie (NYSE:ABBV) shares ticked up before hours today on third-quarter results that beat the consensus forecast.

The North Chicago, Illinois-based company posted profits of $3.2 billion, or $1.78 per share, on sales of $14.34 billion for the three months ended Sept. 30, 2021, for a 37.5% bottom-line gain on sales growth of 11.2%.

Adjusted to exclude one-time items, earnings per share were $3.33, 11¢ ahead of Wall Street, where analysts were looking for sales of $14.3 billion.

“We continue to deliver excellent results, with balanced performance across our portfolio driving double-digit operational sales and EPS growth,” AbbVie Chairman & CEO Richard A. Gonzalez said in a news release. “Based upon our strong momentum, we are increasing our full-year 2021 EPS guidance. We remain highly confident in AbbVie’s long-term outlook and are once again raising our dividend, which has grown over 250% since inception.”

AbbVie …

AbbVie wins CHMP positive opinion to use Skyrizi as an active psoriatic arthritis treatment

AbbVie (NYSE:ABBV) announced that the interleukin-23 antagonist Skyrizi (risankizumab) had received backing from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat active psoriatic arthritis.

The committee recommended the drug for adults with active psoriatic arthritis who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.

CHMP recommended an initial 150-mg of subcutaneous injection of Skyrizi followed by subsequent doses at four weeks and then every 12 weeks after that.

In the U.S., the drug is indicated for certain adults with moderate-to-severe plaque psoriasis. FDA approved the drug in 2019.

In April, North Chicago–based AbbVie announced that it had submitted paperwork to the FDA for the indication of psoriatic arthritis.

Approval for psoriatic arthritis in Europe and the U.S. would elevate AbbVie’s stature in tha…