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AbbVie receives positive opinion from CHMP for injection that treats psoriatic arthritis

AbbVie (NYSE:ABBV) announced today that a European governing body recommended approval for its psoriatic arthritis treatment injection.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of risankizumab (SKYRIZI, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

Get the full story at our sister site, Drug Delivery Business News.

AbbVie’s Rinvoq met primary endpoint in ankylosing spondylitis trial

AbbVie (NYSE:ABBV) has announced positive top-line results in a Phase 3 trial focusing on patients with active ankylosing spondylitis (AS), an inflammatory disease that can eventually lead to fused vertebrae.

The first of two studies, the SELECT-AXIS 2 study examined a daily 15-mg dose of Rinvoq (upadacitinib) in AS patients who had an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARD) therapy.

Rinvoq is a Janus kinase (JAK) inhibitor presently FDA indicated for moderately to severely active rheumatoid arthritis patients. The FDA indication specifically covers patients with a prior history of inadequate response or intolerance to the immunosuppressive drug methotrexate.

The study used the Assessment in SpondyloArthritis International Society (ASAS) 40 response by week 14 as a primary endpoint.

A total of 45% of Rinvoq recipients achieved an ASAS40 score at week 14 compared to 18% of placebo recipients. Similarly, 44% of…

AbbVie’s migraine drug Qulipta wins FDA nod as a preventive migraine treatment

Qulipta (atogepant) from AbbVie (NYSE:ABBV) has become the first calcitonin gene-related peptide (CGRP) agonist to win FDA approval for the preventive treatment of migraine headaches.

In recent years, the agency has approved two related drugs, Ubrelvy (ubrogepant) from AbbVie subsidiary Allergan (NYSE:ABBV) and Nurtec ODT (rimegepant sulfate) from Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN). Both of those products are indicated for the acute treatment of migraines with or without aura.

North Chicago–based AbbVie published results from the pivotal ADVANCE study in The New England Journal of Medicine.

Qulipta bottle image courtesy of AbbVie

Participants in the trial had a mean number of monthly migraine days ranging from 7.5 to 7.9. Recipients of 10-mg atogepant saw an average reduction of 3.7 days in migraine days per month. For the sake of comparison, recipients of 30-mg atogepant …

AbbVie dips despite Street-beating Q2, raised guidance

AbbVie (NYSE:ABBV) shares took a hit today despite second-quarter results that topped the consensus forecast.

The North Chicago-based company posted profits of $769 million, or 42¢ per share, on sales of $14 billion for the three months ended June 30, 2021, marking a massive bottom-line gain from losses of -$739 million last year on sales growth of 33.9%.

Adjusted to exclude one-time items, earnings per share were $3.11, 2¢ ahead of Wall Street, where analysts were looking for sales of $13.6 billion.

“AbbVie delivered another strong quarter and our business continues to perform extremely well across the portfolio, with AbbVie’s new immunology assets contributing more than $1 billion of combined sales in the quarter,” AbbVie chairman & CEO Richard A. Gonzalez said in a news release. “The Allergan integration also continues to track exceptionally well, with both the neuroscience and aesthetics portfolios delivering double-digit …

Alphabet’s Calico renews AbbVie partnership

Calico Life Sciences, an R&D biotech founded in 2013 as a Google subsidiary, is reaffirming its partnership with AbbVie (NYSE: ABBV) it initially formed in 2014. The latest agreement extends the collaboration from 2022 to 2025 while allotting $500 million in additional funding from both companies.

The two companies are collaborating on three clinical stage programs related to immuno-oncology and neurodegeneration. They also have 20 early-stage programs in development.

Calico became part of Alphabet in 2015, when Google decided to restructure as Alphabet as a holding company.

Calico made waves upon launch when it vowed to “cure death.”

At present, Calico and AbbVie currently have two PTPN2 inhibitors in Phase I studies.

The companies plan to continue its work to advance their pipeline of preclinical and clinical drug candidates, which have “first-in-class potential,” according to Gerry Fox, vice president, discovery at …

34 of the most innovative pharmaceutical products

Photo by Myriam Zilles on Unsplash

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.

The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021.

In terms of pharmaceutical agents, the organization selected the following 34 nominees:

Company Drug name

AbbVie Inc.

Rinvoq (upadacitinib)

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma

Adhansia XR (methylp…

AbbVie faces Senate questions related to tax practices

Senate Finance Committee Chair Ron Wyden (D-Ore.) has announced an investigation of AbbVie’s (NYSE: ABBV) tax practices.

In a statement, the senator argued that the company’s tax rate from 2018 to 2020 was 9.5% — less than half of the 20% rate it paid in 2016.

Wyden has sent a letter to AbbVie CEO Richard Gonzalez seeking information about the company’s tax practices.

In the letter, Wyden questioned why the company reported a U.S. pretax loss of $4.5 billion while an offshore pretax profit of $7.9 billion in 2020. “Despite the United States market being the source of most of AbbVie’s revenues and richest price premiums, it appears that the company has consistently reported net losses in the United States while reporting substantial foreign profits,” he wrote.

AbbVie did not immediately respond to a request for comment regarding Wyden’s investigation.

AbbVie is also the subject of a May report from the House Committee on Oversight and Reform…

House report accuses AbbVie of price gouging

A recent report from the House Oversight and Reform Committee concluded that AbbVie (NYSE:ABBV) aggressively increased prices of popular drugs, including the bestseller Humira (adalimumab), which brought in close to $20 billion last year. Approximately $16 billion of those sales were in the U.S.

In recent years, the company also repeatedly increased the price of the small-molecule drug Imbruvica (ibrutinib), according to the report, which is the result of a two-year investigation. AbbVie jointly markets Imbruvica with Janssen (NYSE:JNJ).

An annual supply of Humira costs approximately $77,000, while a year’s worth of Imbruvica is $181,529, according to the House report. The price of the latter has increased 82% since the drug launched in 2013. Outside of the U.S., the cost of Humira has fallen in recent years.

“AbbVie pursued a variety of tactics to increase drug sales while raising prices for Americans, including exploiting the patent system to extend it…

50 of 2020’s best-selling pharmaceuticals

Drug sales in 2020 proved more resilient than many experts anticipated in the early days of the pandemic. Still, the impact on many injectable drugs was tangible in the first half of the year as hospitals initially dissuaded patients from seeking in-person treatment. But sales were generally strong for the full year.

AbbVie’s injectable biologic Humira brought in nearly $20 billion in sales in 2020, with $16 billion in the U.S. alone. A year earlier, sales of the drug were $19.17 billion.

Get the full story from our sister site, Drug Discovery & Development.

AbbVie accuses Alvotech of stealing Humira trade secrets

In a complaint filed in Illinois federal court, AbbVie alleges that the Icelandic biopharma company Alvotech sought to copy its rheumatoid arthritis blockbuster biologic Humira (adalimumab).

The lawsuit accuses Alvotech of hiring a former AbbVie employee, Rongzan Ho, to help it develop a copycat version of Humira.

Ho, a team leader of upstream manufacturing for Humira, was well-versed in the processes involved in manufacturing the drug.

Ho relayed to AbbVie in an exit interview that he was leaving “mainly to learn single-use bioreactors and other new technologies.”

Ho left AbbVie in 2018 to join Abbvie and provided the company with proprietary spreadsheets, according to the complaint, which also accuses Alvotech of poaching other former AbbVie employees.

In November, Alvotech announced that the FDA had accepted its biologics license application to review its proposed Humira biosimilar. “AVT02 is highly similar to its reference product …

AbbVie Q4 earnings beat the consensus forecast

AbbVie (NYSE:ABBV) posted fourth-quarter earnings in line with analysts’ consensus forecast. The firm repeated its recent long-term guidance.

The North Chicago, Ill.-based biopharmaceutical company, reported revenues of $13.9 billion — a 59% increase over the prior year. The quarter’s net income was $36 million, or $0.01 per share. That was considerably less than the earnings of $2.8 billion, or $1.88 per share, in Q4 2019.

Adjusted earnings per shares for the quarter were $2.92, which was $0.08 higher than the midpoint of its guidance. The results beat analysts’ consensus estimate of $2.85 per share on revenue of $13.72 billion.

The company’s performance was driven by double-digit growth from its immunology, hematology-oncology and neuroscience segments. The company’s Botox line achieved 9% growth, “demonstrating a rapid recovery,” according to AbbVie CEO Rick Gonzalez.

AbbVie’s acquisition of Allergan, which was formalized last year, bolstere…

FDA: Thousands of new breast-implant-related illnesses reported

The FDA today reported that it has received nearly 2,500 new reports globally of “breast implant illness” or BII. Reports of new breast implant-related cancer were also up.

BII is not cancer, nor is it a term often found in medical literature, the agency said. But it is frequently used by patients and healthcare providers when reporting adverse events related to breast implants.

The new total of 2,497 new BII reports that the FDA collected globally dates from November 2018 to October 2019. That’s in addition to the 1,080 BII case reports received from January 2008 through October 2018. The agency attributed the increase to heightened awareness from press, social media and its General and Plastic Surgery Devices Advisory Committee meeting held in March 2019.

The top 10 most common BII symptoms reported to the agency include fatigue (49%), brain fog (25%), joint pain (25%), anxiety (24%), hair loss (21%), depression (19%), rash (1…