--- title: PDR Drug Update - February 2023 --- # February 2023 PDR Drug Update  Type Drug Name Here Search - Lead Story - Latest FDA News - FDA Recalls - Labeling Updates Lead Story ##### Combating Recurrent CDI with First-in-Class Live Biotherapeutic *Clostridioides difficile* infection (CDI) continues to be a strong public health threat. The burden on the healthcare system has been significant, with inpatient costs associated with acute CDI nearing $5 billion in the US. Patients and caregivers experience enormous levels of suffering with potentially debilitating and life-threatening diseases such as CDI. Awareness efforts and environmental guidelines put forth by entities such as the CDC and the Infectious Diseases Society of America are helping shape and improve the approach to infection control. An area of particularly urgent need is expanding treatment options for patients with recurrent CDI. A new approval for a first-in-class microbiota-based live biotherapeutic is a step toward addressing this clinical challenge. Dysbiosis, or the imbalance of the microbiome of the gut, may lead to illness in patients, which can be severe. Antibiotics are common culprits of causing this imbalance since both good and bad bacteria are affected during treatment. If a patient carries or is exposed to *C. difficile* spores, the opportunistic bacteria could take hold and cause an infection. This risk is greater with courses of antibiotics, hospitalizations, or older individuals. Some indicators of CDI are diarrhea, nausea, pain, and potentially colitis. In cases of more severe infection, additional complications and disease can result, including dehydration, kidney failure, toxic megacolon, sepsis, and even death. Treatment for CDI can be complicated and lengthy and may only provide a temporary resolution. Up to 30% of individuals who experience CDI develop a recurrent case. As incidences of CDI repeat in a patient, the likelihood of future recurrences increases, putting further stress on their already greatly taxed health. The standard approach to treatment of severe CDI includes [vancomycin](https://www.pdr.net/drug-summary/Vancocin-vancomycin-hydrochloride-802?hsLang=en), which is bactericidal and effective for gram-positive bacteria. It alters the bacterial cell wall and results in cell death. For recurrent CDI, antibody-based therapy is introduced, using [Zinplava (bezlotoxumab)](https://www.pdr.net/drug-summary/Zinplava-bezlotoxumab-23963?hsLang=en), which interferes with the protein toxin production of *C. difficile.* [Fidaxomicin](https://www.pdr.net/drug-summary/Dificid-fidaxomicin-460?hsLang=en) is also used in recurrent CDI, another bactericide for *C. difficile.* Unfortunately, even with repeated targeted treatments, CDI may not be eradicated, and a patient may continue to have recurrences. In order to disrupt the excruciating cycle in patients, clinical measures may need to be taken to correct the dysbiosis through the introduction of a biotherapeutic. However, until recently, there has not been a standardized therapeutic option for gut microbiome restoration. The new FDA approval for [Rebyota (fecal microbiota, live-jslm)](https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7af8a7f6-a441-4dc6-a151-138a89166fbb&version=4) opens the pathway for providing regulated access to treatment that offers a sustained improvement in prevention of recurrent CDI. Rebyota is indicated for the prevention of recurrence of CDI in individuals aged 18 years and older, following antibiotic treatment for recurrent CDI. The treatment consists of a single 150mL rectal dose of a microbiota suspension. The fecal microbiota in Rebyota includes *Bacteroides*, which are beneficial bacteria that assist in the needed diversity in the gut microbiome. Only qualified human donors supply the pathogen-tested fecal matter used to manufacture Rebyota. Screening for potential donors includes blood and stool testing to identify and prevent inclusion of any detrimental bacteria, parasites, or viruses. In clinical trial, 90% of patients with treatment success at the eight-week primary endpoint still experienced a continued outcome of no recurrent CDI for six months. These are encouraging results and showcase the benefit of using microbiota-based therapy. Stay informed about emergent drug information, including gastroenterology therapeutics, by [updating or registering your profile](https://www.pdr.net/login?hsLang=en) to receive email alerts and other critical drug information updates from PDR. You can also stay current by using the official PDR app, *mobile*PDR, available for free from your favorite app stores. Latest FDA News ### FDA New Approvals ##### Brenzavvy The FDA has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 inhibitor. Brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. [Learn more about Brenzavvy](https://theracosbio.com/wp-content/uploads/2023/01/01-23-2023_TheracosBio-Announces-FDA-Approval-of-Brenzavvy.pdf) ##### Jaypirca The FDA has approved Jaypirca (pirtobrutinib) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor. [Learn more about Jaypirca](https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jaypircatm-pirtobrutinib-first-and-only-non) ##### Jesduvroq The FDA has approved Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the once-a-day treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. [Learn more about Jesduvroq](https://www.gsk.com/en-gb/media/press-releases/jesduvroq-daprodustat-approved-by-us-fda-for-anaemia-of-chronic-kidney-disease-in-adults-on-dialysis/) ##### Orserdu The FDA has approved Orserdu (elacestrant) for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. [Learn more about Orserdu](https://www.menarini.com/en-us/news/news-detail/stemline-therapeutics-a-subsidiary-of-menarini-group-receives-us-fda-approval-for-orserdutm-elacestrant-as-the-first-and-only-treatment-specifically-indicated-for-patients-with-esr1-mutations) ##### Rykindo The FDA has approved Rykindo (risperidone) extended-release injectable suspension, for intramuscular use, for treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder in adults. [Learn more about Rykindo](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212849s000lbl.pdf) ### FDA New Indications ##### Brukinsa The FDA has approved Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. This is the fourth approved indication for Brukinsa. [Learn more about Brukinsa](https://ir.beigene.com/news/brukinsa-approved-in-the-u-s-for-chronic-lymphocytic-leukemia/4022a38f-ea68-4b11-ba1f-45478e2c0697/) ##### Keytruda The FDA has approved Keytruda (pembrolizumab) for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4cm), II, or IIIA non-small cell lung cancer (NSCLC). This approval marks the fifth indication for Keytruda-based regimens in NSCLC and the 34th indication for Keytruda in the US. [Learn more about Keytruda](https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-as-adjuvant-treatment-following-surgical-resection-and-platinum-based-chemotherapy-for-patients-with-stage-ib-t2a-%e2%89%a54-centimeters-ii-or-iiia-non/) ##### Revatio The FDA has approved Revatio (sildenafil) for the treatment of pulmonary arterial hypertension (WHO Group I) in pediatric patients (age 1 to 17 years) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise. [Learn more about Revatio](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021845s025lbl.pdf) ##### Tukysa The FDA has approved Tukysa (tucatinib) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. [Learn more about Tukysa](https://investor.seagen.com/press-releases/news-details/2023/Seagen-Announces-FDA-Accelerated-Approval-of-TUKYSA-tucatinib-in-Combination-with-Trastuzumab-for-People-with-Previously-Treated-RAS-Wild-Type-HER2-Positive-Metastatic-Colorectal-Cancer/default.aspx) ### FDA New Dosing ##### Tezspire The FDA has approved Tezspire (tezepelumab-ekko) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Tezspire is the only biologic approved for severe asthma with no phenotype (eg, eosinophilic or allergic) or biomarker limitation within its approved label. [Learn more about Tezspire](https://www.astrazeneca-us.com/media/press-releases/2023/tezspire_approved_for_self_administration_in_the_us_with_a_new_pre_filled_pen.html)   FDA Recalls ### FDA Recalls ##### Edgewell Personal Care Company Banana Boat Sunscreen Edgewell Personal Care Company expanded its voluntary nationwide recall of three batches of Banana Boat hair and scalp sunscreen spray SPF 30, to the consumer level. One additional batch has been added to the original recall announced on July 29, 2022. [Learn more about the Edgewell Personal Care Company Banana Boat sunscreen recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edgewell-personal-care-issues-voluntary-nationwide-recall-banana-boat-hair-scalp-sunscreen-due-0) ##### Ibsa Tirosint-Sol IBSA Pharma Inc. is voluntarily recalling 27 lots of Tirosint-Sol (levothyroxine sodium) oral solution to the consumer level. This voluntary recall has been initiated because these lots may be subpotent. The company's analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots. [Learn more about the Tirosint-Sol recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ibsa-pharma-inc-issues-voluntary-nationwide-recall-select-lots-tirosintr-sol-levothyroxine-sodium) Labeling Updates #### Labeling Updates - Key - ![](https://www.pdr.net/hubfs/lynton/homepage/BlackBox_opt.jpeg) Boxed Warning - ![](https://www.pdr.net/hubfs/lynton/homepage/Triangle_opt.jpeg) Other Warnings* *Warnings and Precautions; Adverse Reactions; Drug Interactions; and Contraindications - ![](https://www.pdr.net/hubfs/lynton/homepage/Circle_opt.jpeg) Updates to Indications/Dosage - ![](https://www.pdr.net/hubfs/lynton/homepage/Diamond_opt.jpeg) Other Updates† †Other labeling changes; added to PDR database | No Avycaz boxed warning | ![Avycaz has Other Warnings](https://www.pdr.net/hubfs/lynton/homepage/Triangle_opt.jpeg "Other Warnings") | No Avycaz Indications/Dosage Updates | ![Avycaz has Other Updates](https://www.pdr.net/hubfs/lynton/homepage/Diamond_opt.jpeg "Other Updates") | [**Avycaz **(avibactam/ceftazidime)](https://www.pdr.net/full-prescribing-information?druglabelid=3692&hsLang=en) | | --- | --- | --- | --- | --- | | No Lo Loestrin Fe boxed warning | No Lo Loestrin Fe Other Warnings | No Lo Loestrin Fe Indications/Dosage Updates | ![Lo Loestrin Fe has Other Updates](https://www.pdr.net/hubfs/lynton/homepage/Diamond_opt.jpeg "Other Updates") | [**Lo Loestrin Fe**(ethinyl estradiol/ferrous fumarate/norethindrone acetate)](https://www.pdr.net/full-prescribing-information?druglabelid=613&hsLang=en) | | No Ozurdex boxed warning | No Ozurdex Other Warnings | No Ozurdex Indications/Dosage Updates | ![Ozurdex has Other Updates](https://www.pdr.net/hubfs/lynton/homepage/Diamond_opt.jpeg "Other Updates") | [**Ozurdex **(dexamethasone)](https://www.pdr.net/full-prescribing-information?druglabelid=56&hsLang=en) | | No Skyrizi boxed warning | No Skyrizi Other Warnings | No Skyrizi Indications/Dosage Updates | ![Skyrizi has Other Updates](https://www.pdr.net/hubfs/lynton/homepage/Diamond_opt.jpeg "Other Updates") | [**Skyrizi **(risankizumab-rzaa)](https://www.pdr.net/full-prescribing-information?druglabelid=24336&hsLang=en) | | --- | --- | --- | --- | --- | | No Vraylar boxed warning | ![Vraylar has Other Warnings](https://www.pdr.net/hubfs/lynton/homepage/Triangle_opt.jpeg "Other Warnings") | ![Vraylar has Indications/Dosage Updates](https://www.pdr.net/hubfs/lynton/homepage/Circle_opt.jpeg "Indications/Dosage") | ![Vraylar has Other Updates](https://www.pdr.net/hubfs/lynton/homepage/Diamond_opt.jpeg "Other Updates") | [**Vraylar **(cariprazine)](https://www.pdr.net/full-prescribing-information?druglabelid=3792&hsLang=en) | ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net#website", "@type" : "Website", "name" : "", "potentialAction" : { "@type" : "SearchAction", "query-input" : "required name=search_term_string", "target" : { "@type" : "EntryPoint", "urlTemplate" : "https://www.pdr.net/?site-search={search_term_string}" } }, "publisher" : { "@id" : "https://www.pdr.net#organization" }, "url" : "https://www.pdr.net" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net/edrug-updates/feb2023#webpage", "@type" : "WebPage", "about" : { "@id" : "https://www.pdr.net#organization" }, "dateModified" : "2024-10-01T12:0000+0000", "datePublished" : "2023-05-31T14:4827+0000", "description" : "", "inLanguage" : null, "isPartOf" : { "@id" : "https://www.pdr.net#website" }, "name" : "PDR Drug Update - February 2023", "url" : "https://www.pdr.net/edrug-updates/feb2023" } ```