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The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back

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The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19 vaccine. Although Comirnaty maintained its position as the best-selling pharmaceutical of 2022, it experienced a roughly 5% drop in sales compared to the previous year.

As the best-selling pharmaceuticals of 2022 demonstrate, signs are emerging that the reign of COVID-19 vaccines and other therapies appears to be slipping.. The two companies — and Moderna — plan on hiking prices to address the weakening demand.

Humira: The second best-selling pharmaceutical of 2022 looking strong

Meanwhile, the heavyweight tumor necrosis factor (TNF) block…

AbbVie and Janssen voluntarily withdraw Imbruvica from accelerated approvals for MCL and MZL

AbbVie (NYSE:ABBV) and Janssen Pharmaceutical (NYSE:JNJ) have revealed their intent to voluntarily withdraw the accelerated approvals for Imbruvica (ibrutinib) for patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the U.S.

Ibrutinib is a selective Bruton’s tyrosine kinase (BTK).

The main reasons for the move relate to FDA’s request for additional studies to confirm clinical benefits that relate to the accelerated approval status granted by the FDA for MCL and MZL. Initially, FDA authorized the accelerated approval program for the two indications following the publication of positive overall response rate data in phase 2 trials.

While the phase 3 shine study in previously untreated MCL met its primary endpoint of progression-free survival, there was an increased rate of adverse reactions when combining Imbruvica and chemotherapy compared to the placebo-controlled arm.

Conversely, the phase 3 SELENE study in re…

Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance

A robotic arm transfers Humira pens from the conveyor to two-pack cartons. [Image from AbbVie]

The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.

The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,…

AbbVie and Capsida join forces to target serious eye diseases

AbbVie (NYSE:ABBV) will work with the gene therapy platform company Capsida Biotherapeutics (Thousand Oaks, California) to develop serious eye diseases with few treatment options. The partnership will unite AbbVie’s development and commercialization capabilities with Capsida’s adeno-associated virus (AAV) engineering platform. AbbVie will also help explore therapeutic cargo approaches. The companies plan on identifying and advancing three programs.

The collaboration will center around Capsida’s AAV engineering platform and manufacturing capabilities to develop novel ophthalmological therapies.

Under the terms of the agreement, AbbVie will pay Capsida an upfront payment of $70 million. In addition, AbbVie could also make potential equity investments in the expanded agreement.

Capsida is also eligible for up to $595 million in option fees and R&D milestones if the company reaches commercial milestones. It could also receive mid-to-hig…

AbbVie files sNDA with FDA to expand atogepant label

AbbVie (NYSE:ABBV) has submitted a supplemental New Drug Application (sNDA) to the FDA to support the use of atogepant (Qulipta) as a preventive treatment of both episodic and chronic migraine.

FDA approved the drug in September 2021 as a preventive treatment of episodic migraine in adults.

In March 2022, AbbVie announced that the Phase 3 PROGRESS study testing atogepant met its primary endpoint of reducing mean monthly migraine days over placebo in patients with chronic migraine.

In its recent sNDA filing, AbbVie included data from the pivotal Phase 3 PROGRESS trial in patients with chronic migraine. The placebo-controlled study met its primary endpoint, which related to a statistically significant reduction from baseline in mean migraine days per month.

Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) developed as a preventive migraine therapy.

Q…

AbbVie’s Skyrizi becomes first drug to win FDA nod for Crohn’s disease

AbbVie (NYSE:ABBV) has announced that FDA has approved Skyrizi (risankizumab-rzaa) as the first interleukin-23 (IL-23) inhibitor to treat adults with moderately to severely active Crohn’s disease (CD).

Skyrizi is also FDA-approved as a treatment for moderate to severe plaque psoriasis and active psoriatic arthritis.

IL-23 inhibitors have surged in popularity recently, given their ability to treat diseases such as plaque psoriasis.

Janssen’s Stelara (ustekinumab), which inhibits both IL-12 and IL-23, has racked up the most indications. It is now FDA-approved for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Stelara was first FDA-approved in 2009.

Skyrizi is a newer drug, winning FDA approval for plaque psoriasis in 2019.

A 2019 analysis found that Skyrizi had higher efficacy than placebo and Stelara in treating moderate-to-severe chronic plaque psoriasis.

AbbVie touts positive cariprazine data in major depressive disorder

The schizophrenia and bipolar drug cariprazine (Vraylar) fared well as an adjunctive therapy in the Phase 3 3111-301-001 study involving patients with major depressive disorder (MDD).

AbbVie (NYSE:ABBV) is aiming to win a new FDA indication for the drug as an adjunctive treatment of MDD by the end of the year.

According to MedPage Today, 44% of patients in the 1.5-mg arm had at least a 50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score by week 2 of treatment.

The company did not divulge significant data in a news release, stating that patients receiving a 1.5mg/day dose of the drug met the primary endpoint of statistically significant improvement based on the MADRS at week six compared to placebo. Patients receiving 3.0 mg/day per day had an improved MADRS total score, but the results were not statistically significant.

Patients in the 1.5 mg group also saw improvements in their scores on the Hamilton Depression Rating Sc…

AbbVie’s Rinvoq supports clinical remission in Phase 3 Crohn’s disease study

AbbVie (NYSE:ABBV) has revealed positive topline results from the U-ENDURE Phase 3 study investigating 15- and 30-mg doses of Rinvoq (upadacitinib) in adults with moderate to severe Crohn’s disease.

Recipients who received either dose met the co-primary endpoints of endoscopic response and clinical remission, AbbVie announced. More than one-third (36%) of participants who received 15 mg of upadacitinib achieved clinical remission at week 52. A total of 46% of those receiving the 30-mg dose achieved the same benchmark, compared with 14% of placebo recipients.

Subjects also achieved the secondary endpoint of endoscopic remission at 52 weeks compared to placebo.

Study participants were poor candidates for conventional or biologic therapy.

The study defined clinical remission using the Crohn’s Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP).

Rinvoq first won FDA approval in 2019 for rheumatoid ar…

Teva and Allergan reportedly agree to pay $5B billion to settle opioid allegations

[Prescription pill bottle image courtesy of Pexels]

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and AbbVie unit Allergan Plc (NYSE:ABBV) could pay more than $5 billion in total to settle some 3,500 opioid lawsuits, according to Bloomberg. While the two companies are willing to settle the suits in the consolidated case, the deal has not been finalized.

The consolidated case is titled In Re National Prescription Opioid Litigation, 17-MD-2804, U.S. District Court, Northern District of Ohio (Cleveland).

Teva and Allergan have reportedly been in mediation for more than a year.

In 2016, Teva completed a $40.5 billion acquisition of Allergan’s generic business, including generic opioids.

In 2020, AbbVie acquired Allergan.

Earlier this year, Teva Pharmaceuticals and AbbVie reached a deal with Rhode Island for a total of $28.5 million to settle opioid-related claims.

Teva entered…

FDA approves AbbVie’s Rinvoq for active ankylosing spondylitis

AbbVie (NYSE:ABBV) has notched a new approval for the Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine.

The drug was first approved for treating rheumatoid arthritis in 2019. Indications followed for psoriatic arthritis, atopic dermatitis and ulcerative colitis.

The ankylosing spondylitis indication is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) inhibitors.

AbbVie provided data from two pivotal studies showing the drug supported The Assessment in SpondyloArthritis international Society 40% (ASAS40) benchmark to win the latest indication.

Rinvoq image courtesy of AbbVie

ASAS40 refers to an at least 40% improvement in three out of four domains related to back pain, disease activity, physical function and inflammation. The ASAS40 respons…

10 leading pharma executives you need to know

Pfizer CEO Dr. Albert Bourla [Image courtesy of Pfizer/Business Roundtable]Given the complexity of the pharmaceutical business, it can be challenging to gauge the performance of any chief executive in the space.

That said, CEOs’ annualized return over tenure as CEO over their term can hint at performance. In addition, rating sites like Glassdoor also indicate CEOs’ popularity.

Here, we parsed a range of metrics, including CEOs’ approval ratings, their ability to navigate the pandemic and their firms’ stock performance over time, to identify ten leading pharma executives.

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

50 of 2021’s best-selling pharmaceuticals

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments.

Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for the Pfizer-BioNTech vaccine is likely to keep Pfizer as the biggest pharma firm of 2022 as well. (Look out for more insights from our annual Pharma 50 report.)

The second-best-selling drug of 2021 was AbbVie’s injectable biologic Humira, which generated $20.7 billion in sales. Next in line was Moderna’s COVID-19 vaccine, which drove $17.7 billion in revenue. Merck’s megablockbuster Keytruda rounded out the top four with $17.2 billion in revenue.

Novartis and Roche have struggled to commercialize COVID-19 therapies, although the latter has introduced a series of SARS-CoV-2 diagnostics. T…