May 2023
PDR Drug Update
- Lead Story
- Latest FDA News
- FDA Recalls & Alerts
- Labeling Updates
Closing Treatment Gaps for Candidemia and Invasive Candidiasis
Conservative estimates of cases of candidemia in the US stand at approximately 25,000. Mortality rates among candidemia patients can be as high as nearly 50%. The opportunistic pathogens are troublesome and often life-threatening for some at-risk patients. The Candida that lives on and in the body does not cause health issues for most individuals. Certain circumstances and comorbidities may predispose some people to bloodstream infections such as candidemia or even deeper-seated occurrences like invasive candidiasis that can arise in the heart, bones, or other internal organs. Patients with immunosuppression or recent surgery are susceptible to fungal infection, especially where skin or mucosal barriers are disrupted. Of particular risk are those who require central venous catheters. All these circumstances create vulnerabilities in patients, and invasive infections that can occur with Candida can become significantly more difficult to treat and even result in death.
After a patient is diagnosed with candidemia or invasive candidiasis, typically by taking a blood culture, treatment will begin as soon as possible. In most cases, the recommended antifungal treatment will be one of the newest antifungals, a class known as echinocandins. Until now, three echinocandins have been available, caspofungin, micafungin, and anidulafungin. As a class, they have been preferred for fungicidal use due to their unique mechanism of action. They inhibit β-D-glucan synthase, which is necessary within cell wall synthesis. Since mammalian cells do not have cell walls, there are minimal toxic adverse effects when these agents are used in humans. Coupled with high efficiency in invasive infection, the benefits of the class make it a promising area to research and develop.
In 2018, the newest echinocandin, rezafungin, received a fast-track and qualified infectious disease product designations from the FDA. The differentiation of rezafungin compared to the other echinocandins that preceded it is that it demonstrated a higher level of stability while in solution and has been modified for improved pharmacokinetics. Thus, the stage was set for continued study to determine the clinical significance of rezafungin. After completing its clinical trials, the drug was reviewed by the FDA’s Antimicrobial Drugs Advisory Committee, and ultimately the agency decided that its benefit-risk profile was, in fact, favorable. In March 2023, Rezzayo (rezafungin) became the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade. Its once-weekly dosing is one of its most notable traits, as the previously approved drugs in its class require daily dosing. Simplified dosing can greatly help patients and caregivers when fighting challenging infections. The official indication for Rezzayo states that it is for use in patients aged 18 years or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data for Rezzayo. Its label includes a limitation of use statement explaining that it has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
As treatment-resistant pathogens continue to emerge, the clinical tools and therapies to fight them must continue to be developed with precision and effectiveness at the forefront. New approvals like Rezzayo help healthcare providers keep pace with the complexities of infection in patients and serve to close gaps with current therapies. Stay informed about emergent drug information, including treatment options for serious fungal infections, by updating or registering your profile to receive email alerts and other critical drug information updates from PDR. You can also stay current by using the official PDR app, mobilePDR, available for free from your favorite app stores.
FDA New Approvals
Abilify Asimtufii
The FDA has approved Abilify Asimtufii (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. Learn more about Abilify Asimtufii
Arexvy
The FDA has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals aged 60 years and older. This is the first RSV vaccine for older adults to be approved anywhere in the world. Learn more about Arexvy
Elfabrio
The FDA has approved Elfabrio (pegunigalsidase alfa) in the US for the treatment of adult patients with Fabry disease. Elfabrio is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme. Learn more about Elfabrio
Lumryz
The FDA has approved Lumryz (sodium oxybate) for extended-release oral suspension for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. With final approval, Lumryz becomes the first and only FDA-approved once-at-bedtime oxybate for people with narcolepsy. Learn more about Lumryz
Mydcombi
The FDA has approved Mydcombi (phenylephrine HCl/tropicamide) 2.5%/1% ophthalmic spray for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. This represents the first approved fixed-dose combination of tropicamide and phenylephrine in the US. Learn more about Mydcombi
Omisirge
The FDA has approved Omisirge (omidubicel-onlv) for use in adult and pediatric patients aged 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Learn more about Omisirge
Prevnar 20
The FDA has approved Prevnar 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children aged six weeks through 17 years, and for the prevention of otitis media in infants aged six weeks through five years caused by the original seven serotypes contained in Prevnar. Learn more about Prevnar 20
Qalsody
The FDA has approved Qalsody (tofersen) 100mg/15mL injection for the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 gene. This indication is approved under accelerated approval. Learn more about Qalsody
Rizafilm
The FDA has approved Rizafilm (rizatriptan) oral film for acute treatment of migraine with or without aura in adults and pediatric patients aged 12 to 17 years weighing 40kg or more. Rizafilm is a proprietary oral thin film formulation of rizatriptan benzoate. Learn more about Rizafilm
Uzedy
The FDA has approved Uzedy (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. Uzedy is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq a proprietary copolymer technology. Learn more about Uzedy
Vowst
The FDA has approved Vowst (fecal microbiota spores, live-brpk), an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI. Vowst is not indicated for the treatment of CDI. Learn more about Vowst
FDA New Indications
Farxiga
The FDA has approved Farxiga (dapagliflozin) to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure (HF) visits in adults with HF. Farxiga was previously approved for adults with HF with reduced ejection fraction in the US. Learn more about Farxiga
Kalydeco
The FDA has approved Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) aged one month to less than four months old who have at least one mutation in their CF transmembrane conductance regulator gene that is responsive to Kalydeco based on clinical and/or in vitro assay data. Kalydeco is already approved for the treatment of CF in patients aged four months and older. Learn more about Kalydeco
Qulipta
The FDA has approved an expanded indication for Qulipta (atogepant) for the preventive treatment of migraine in adults. The approval makes Qulipta the first and only oral calcitonin gene-related peptide receptor antagonist approved to prevent episodic and chronic migraine. Learn more about Qulipta
Sogroya
The FDA has approved a new indication for Sogroya (somapacitan-beco) injection 5mg, 10mg, or 15mg for the treatment of children aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone. With this new indication, Sogroya becomes the first and only once-weekly growth hormone treatment for both children and adults. Learn more about Sogroya
Trikafta
The FDA has approved the expanded use of Trikafta (elexacaftor/ivacaftor/tezacaftor; ivacaftor) to include children with cystic fibrosis (CF) ages 2 through 5 years who have at least one F508del mutation in the CF transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data. The FDA previously approved Trikafta for use in people with CF aged 6 years and older with at least one F508del mutation or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data. Learn more about Trikafta
FDA New Combinations
Polivy + Rituxan
The FDA has approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index of two or greater. Learn more about Polivy + Rituxan
FDA New Dosing
Lupron Depot-Ped
The FDA has approved Lupron Depot-Ped (leuprolide acetate for depot suspension) to include the addition of a 45mg 6-month dosing regimen for the approved central precocious puberty indication. Learn more about Lupron Depot-Ped
Vimpat
The FDA has approved Vimpat (lacosamide) for the use of alternate loading dosing for initiation of lacosamide treatment in partial-onset seizure patients aged ≥1 month to <17 years and in primary generalized tonic-clonic seizure patients aged ≥4 to <17 years, across all formulations. Learn more about Vimpat
FDA Recalls
Akorn Products
Akorn Operating Company LLC filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shut down all operations and terminated all its employees at all domestic US sites. The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products due to the closures and discontinuation of the quality activities of these marketed products. Learn more about the Akorn products recall
Family Dollar Advil Products
Family Dollar is initiating a voluntary retail-level product recall of certain over-the-counter drug products regulated by the FDA that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 due to product being stored by Family Dollar outside of labeled temperature requirements. Learn more about the Family Dollar Advil products recall
Gear Isle Products
Gear Isle is voluntarily recalling several lots of male enhancement products to the consumer level. FDA analysis has found the products to be tainted with sildenafil and tadalafil. Learn more about the Gear Isle products recall
Teva Fentanyl Buccal Tablets
Teva Pharmaceuticals has initiated a voluntary nationwide recall of specific lots of various strengths of fentanyl buccal tablets to the consumer level. Teva manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. This recall was initiated because safety updates were omitted in the Product Insert/Medication Guide provided with these recalled lots. Learn more about the Teva Fentanyl Buccal Tablets recall
FDA Alerts
Opioid Pain Medicines
The FDA is making several updates to the prescribing information of opioid pain medicines to provide additional guidance on using these powerful medicines. The FDA has also determined that a new warning is needed about opioid-induced hyperalgesia, which is when an opioid that is prescribed and taken for pain relief causes hyperalgesia or allodynia. Learn more about the opioid pain medicines drug safety communication
Unapproved Drugs for Alertness and Energy
The FDA is warning consumers not to purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy. These products are inhalants and primarily contain ammonia. Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction. Learn more about the unapproved drugs for alertness and energy alert
Labeling Updates
- Key
-
Boxed Warning
-
Other Warnings*
*Warnings and Precautions; Adverse Reactions; Drug Interactions; and Contraindications
-
Updates to Indications/Dosage
-
Other Updates†
†Other labeling changes; added to PDR database
No Brukinsa boxed warning | No Brukinsa Other Warnings | No Brukinsa Indications/Dosage Updates | Brukinsa(zanubrutinib) | |
No Depakote Tablets boxed warning | Depakote Tablets (divalproex sodium) | |||
No Skyrizi boxed warning | No Skyrizi Other Warnings | Skyrizi (risankizumab-rzaa) |
No Vuity boxed warning | Vuity (pilocarpine hydrochloride) | |||
No Depakote ER boxed warning | No Depakote ER Other Warnings | No Depakote ER Other Updates | Depakote ER(divalproex sodium) |