ABRYVSO™

Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Abrysvo™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. Abrysvo is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

RSV is a contagious virus and a common cause of respiratory illness worldwide. The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death. In the U.S., the burden RSV causes in older adults is considerable. The severity of RSV disease can increase with age and comorbidities, such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on June 21, 2023, to discuss recommendations for the appropriate use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall.

Earlier this month, Pfizer reported positive top-line results from the Phase 3 study evaluating the safety and immunogenicity of Abrysvo co-administered with seasonal inactivated influenza vaccine (SIIV) in adults 65 years and older. Pfizer intends to publish these results in a peer-reviewed scientific journal. Earlier this month, Pfizer also announced it would be initiating multiple clinical trials evaluating RSVpreF in healthy children ages 2-5; children ages 5-18 with underlying medical conditions; adults ages 18-60 at high-risk due to underlying medical conditions; and adults ages 18 and older who are immunocompromised and at high-risk for RSV.

The FDA’s decision is based on the data from the pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study in older adults immunized against RSV disease). RENOIR is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older. RENOIR has enrolled approximately 37,000 participants, randomized to receive RSVpreF 120 μg or placebo in a 1:1 ratio. The results were recently published in The New England Journal of Medicine. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.

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POSLUMA®

FDA Approves Posluma (flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer

Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval for its optimized, high-affinity radiohybrid (rh) Prostate-Specific Membrane Antigen (PSMA)-targeted PET imaging agent, Posluma® (flotufolastat F 18) injection (formerly referred to as F-rhPSMA-7.3). Posluma is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

It is the first and only FDA-approved, PSMA-targeted imaging agent developed with proprietary radiohybrid (rh) technology. Posluma will be commercially available in early June 2023, through certain radiopharmacies in the national radiopharmacy network of Blue Earth Diagnostics’ commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company. It will become increasingly available nationally in the coming months.

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INPEFA™

FDA Approves Inpefa (sotagliflozin) for the Treatment of Heart Failure

Lexicon Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Inpefa™ (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:

• Heart failure or

• Type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

The broad label encompasses heart failure patients across the full range of left ventricular ejection fraction (LVEF), including preserved ejection fraction and reduced ejection fraction, and for patients with or without diabetes.

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Researchers Explore Ozempic as a Potential Addiction Treatment

Following patient testimony on its ability to curb addiction, researchers have begun preclinical studies exploring Ozempic as a potential addiction treatment.

Gaining popularity from celebrity endorsements and public speculation, Ozempic has become a staple weight loss drug in the United States. However, researchers speculate that the medication could significantly surpass weight management as a potential addiction treatment.

Ozempic, generically known as semaglutide, is a glucagon-like peptide (GLP) receptor agonist. Alongside lifestyle changes, such as diet and exercise, the medication has been proven to facilitate weight loss. While the drug has been used off-label for weight loss, it has only been approved for glycemic control and reduced cardiovascular risk in patients with type 2 diabetes.

Patient testimonies published in the Atlantic earlier this month reported reduced cravings for addictive substances, including processed food, alcohol, shopping, nicotine, and more. Supported by data from multiple existing studies, researchers have decided to analyze semaglutide’s utility as an addiction treatment in preclinical studies.

A 2022 article published in the British Journal of Pharmacology explored the role of GLP-1 on addictive disorders, finding that GLP-1 is mediated through dopamine signaling, implying a role in the brain’s reward pathway.

A more recent study published on May 16, 2023, in the Journal of Clinical Investigation detailed a preclinical trial on mice that assessed the impact of the drug on alcohol use. According to the study, semaglutide reduced alcohol intake in mice, with effects increasing as the dose was elevated, mimicking the reduced food consumption for patients treated with the medication to manage weight loss.

Additional insights revealed that, in rats who did not have any alcohol, semaglutide increased the frequency of spontaneous inhibitory postsynaptic currents in the central nucleus of the amygdala and the infralimbic cortex neurons.

Researchers in the study concluded, “the GLP-1 analogue semaglutide decreased alcohol intake across different drinking models and species and modulated central GABA neurotransmission in rodents, providing support for clinical testing of semaglutide as a potential novel pharmacotherapy for AUD.”

With patient testimony and preclinical research to support semaglutide use for addiction treatment, researchers are exploring the theories more. For example, two ongoing clinical trials conducted by the University of North Carolina, Chapel Hill, are studying the effects of semaglutide on nicotine and alcohol addiction.

While not quite at the clinical trial phase, these theories may have implications for the expanded use of Ozempic.

PAXLOVID™

FDA Approves Paxlovid (nirmatrelvir tablets and ritonavir tablets) for Adult Patients at High Risk of
Progression to Severe COVID-19

Pfizer Inc. announced that the U.S. Food and Drug Administration approved Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid has been available in the U.S. since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. More than 11.6 million treatment courses of Paxlovid have been prescribed in the U.S. to date.

Based on the relative risk reduction seen across both clinical and real-world data, the FDA provided an estimate in March 2023 that more than 1,500 lives could be saved, and 13,000 hospitalizations avoided each week with Paxlovid use in eligible patients. At this time, the U.S. government will continue to oversee the distribution of Paxlovid, and U.S. residents eligible for Paxlovid will continue to receive the medicine at no charge.*

Paxlovid remains available for eligible children, 12 to 17 years of age (and weighing at least 40 kg), under the existing EUA. Pfizer continues to gather pediatric data from the ongoing clinical trial, EPIC-Peds (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients) and intends to submit a supplemental New Drug Application (sNDA) to support the FDA approval of Paxlovid in children at a future date.

Paxlovid is currently approved or authorized for conditional or emergency use in more than 70 countries across the globe to treat COVID-19 patients who are at increased risk for progressing to severe illness. Paxlovid is now supplied in two different dose packs, one for standard dosing and one for moderate renal impairment dosing.

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YUFLYMA

FDA Approves Yuflyma (adalimumab-aaty), a Biosimilar to Humira

Celltrion USA has announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar. The FDA granted approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Yuflyma is Celltrion’s fifth biosimilar and second anti-TNF biosimilar approved for use in the United States. Yuflyma will offer patients pre-filled syringe and autoinjector administration options to meet different preferences and needs.

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BRIXADI

FDA Approves Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

Braeburn Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product.

Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support. Brixadi is to be administered only by healthcare providers in a healthcare setting and will be available in the U.S. in September 2023.

Brixadi is the first and only weekly and monthly subcutaneous injection for moderate to severe OUD and is the only buprenorphine injectable that utilizes FluidCrystal®* Injection Depot Technology. Patients currently being treated with oral buprenorphine-containing products can be switched to equivalent doses of Brixadi Weekly or Brixadi Monthly in accordance with the Prescribing Information for Brixadi.

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XACDURO®

FDA Approves Xacduro (sulbactam and durlobactam) for the Treatment of Serious Infections Caused by Acinetobacter

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Xacduro® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). The FDA granted the approval of Xacduro to Entasis Therapeutics.

According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines. Xacduro consists of sulbactam, a drug structurally related to penicillin, and durlobactam. Sulbactam kills A. baumannii whereas durlobactam protects sulbactam from being degraded by enzymes that may be produced by A. baumannii. Xacduro is administered by intravenous infusion.

The FDA approval was based on an array of scientific evidence, including results from the landmark Phase 3 ATTACK trial evaluating the safety and efficacy of Xacduro versus colistin in patients with infections caused by Acinetobacter. In the trial, Xacduro demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenemresistant Acinetobacter infections and a significant difference in clinical cure rates. Xacduro was well tolerated and exhibited a favorable safety profile across the clinical program.

The most common adverse reaction with Xacduro was liver function test abnormalities. Xacduro comes with certain warnings and precautions, such as hypersensitivity reactions and Clostridiodes difficile-associated diarrhea.

Patients should not receive Xacduro if they have a history of known severe hypersensitivity to components of Xacduro, sulbactam or other beta-lactam antibacterial drugs.

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Biosimilars

US FDA Approves the Cyltezo® Pen, a New Autoinjector Option

Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira® (adalimumab). Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases. The 40 mg/0.8 mL pre-filled Cyltezo Pen will be available in two-, four- and six-pack options on July 1, 2023.

The patient-centered design of the pen features a one-button, three-step activation, with 100% drug visibility and a protected needle.

INDICATIONS FOR CYLTEZO®(adalimumab-adbm) injection, for subcutaneous use

Rheumatoid Arthritis: Cyltezo is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Cyltezo can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis: Cyltezo is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Cyltezo can be used alone or in combination with methotrexate.

Psoriatic Arthritis: Cyltezo is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Cyltezo can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis: Cyltezo is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease: Cyltezo is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis: Cyltezo is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.

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OPVEE

FDA Approves Opvee (nalmefene hydrochloride) Prescription Nasal Spray to Reverse Opioid Overdose

Indivior PLC has announced that the U.S. Food and Drug Administration (FDA) approved Opvee® (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.

Opvee was designed to address the challenges of today’s opioid crisis. Opvee is an emergency treatment for the fast reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl.

Opvee contains nalmefene, an opioid receptor antagonist that provides fast onset and long duration reversal of opioid-induced respiratory depression, which is the primary cause of opioid overdose injury and death. The speed of action, long duration, and high potency of fentanyl and other synthetic opioids are driving unprecedented overdose deaths across a broader range of ages, and they are now a leading cause of death for people ages 18 to 45. For each opioid-induced fatality, it has been estimated that there are an additional 6.4-8.4 non-fatal overdoses that can lead to long-term physical and mental disability. Opvee is expected to be in the market in Q4 of 2023.

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