Novavax Receives Emergency Use Authorization for Its COVID-9 Booster

The Centers for Disease Control and Prevention (CDC) added its recommendation soon after the U.S. Food and Drug Administration (FDA) amended its emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted, on Oct. 19, 2022. In addition to using as a two-dose initial vaccine series for individuals aged 12 years old and older, the intramuscularly (IM)-administered vaccine now also is authorized as a first booster six months or longer after an adult (at least 18 years old) finishes the initial two-shot series with Novavax or another FDA-approved/authorized COVID vaccine. Patients eligible for a booster inoculation with the Novavax vaccine are unable or unwilling to be boosted with a bivalent mRNA-based vaccine, so they are at risk of not being boosted at all. Novavax cannot be used after another booster has been given. Developed from a recombinant COVID-19 spike protein, the Novavax vaccine includes an adjuvant (an immune enhancer) that improves its effectiveness. For additional information, please see the Fact Sheet for Healthcare Providers, which includes full prescribing information; and the Fact Sheet for Patients and Caregivers.

FDA Approves New Formulation of Menveo

GlaxoSmithKline received FDA approval on Oct. 14, 2022, for a new form of Menveo [meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine] solution for injection. Previously available only in two separate vials that had to be reconstituted and combined before injection, the vaccine now comes premixed in a single vial. It is administered IM – typically for children at two months, four months, six months, and 12 months of age. Alternately, children who are beginning vaccinations at seven months up to 23 months of age should receive two doses that are given three or more months apart with the second dose after the child’s second birthday. If the individual has not been vaccinated for meningitis before becoming two years old, only one vaccination is needed. At four or more years following the latest shot, a booster is recommended for people between the ages of 15 years old and 55 years old – especially those, such as new members of the armed forces, freshmen in universities, and patients who have immunocompromising conditions, who may have a higher chance of contracting meningitis or of developing severe complications from it. A limited launch of the new one-vial formulation is planned for federal clients in the U.S., with general distribution expected by the middle of 2023. Complete prescribing information is here.

New Dosing Approved for Turalio

Turalio^® (pexidartinib – Daiichi Sankyo) capsules were granted a new dosage strength and administration regimen on Oct. 14, 2022. Initially, FDA approved on Aug. 2, 2019, the colony-stimulating factor-1 receptor (CSF-1R) inhibitor is the only drug specifically indicated for treating adults who have a rare noncancerous joint condition – tenosynovial giant cell tumor (TGCT) that cannot be removed surgically. At an estimated incidence of 11 cases per million, approximately 2,500 Americans may be affected by TGCT, which attacks joints and tendons, seriously interfering with the patient’s ability to function normally. Originally, the recommended dosing was 400mg (two 200mg capsules) two times a day. Because eating at the same time as taking the drug increases the body’s absorption of Turalio, the initial directions were to take it at least one hour before or two hours after a meal or snack. Findings from a continued clinical study showed the dose could be lowered and the food restrictions modified with no loss of effectiveness, but a possible reduction in the risk of side effects. Therefore, the dose has been reduced to 250mg (two not-yet-available 125mg capsules) taken twice daily along with low-fat foods. Patients will be switched to the new strength and dosing schedule during the first quarter of 2023 as the 200mg capsules are phased out. Its possibility of causing liver damage requires Turalio to have a boxed warning, a risk evaluation and mitigation strategy (REMS), and restricted distribution. Here is it’s revised prescribing information.

Truseltiq Being Discontinued

In a press release dated Oct. 14, 2022, Helsinn Healthcare announced its intention to stop supplying Truseltiq^™ (infigratinib) capsules in the United States. Awarded Accelerated Approval by the FDA in May 2021, Truseltiq is an oral tyrosine kinase inhibitor (TKI) that is specific for fibroblast growth factor 2 (FGFR2). It was indicated for treating adults who have inoperable cholangiocarcinoma (bile duct cancer) that is verified to have an FGFR2 fusion or rearrangement and that has spread despite previous therapy. Helsinn stated that its reasons for withdrawing the drug’s new drug application (NDA) as treatment of cholangiocarcinoma are commercial, not related to the drug’s effectiveness or safety. A business partner, BridgeBio, will continue its clinical trials of infigratinib for other conditions, including achondroplasia and some types of stomach cancer. Other FGFR-targeted drugs available in the U.S. to treat cancer of the bile ducts are Pemazyre^® (pemagatinib – Incyte Pharmaceuticals) tablets, which received the FDA’s Accelerated Approval in April 2020, and Lytgobi^® (futibatinib – Taiho Oncology) tablets, given Accelerated Approval on Sept. 30, 2022.

FDA Advisory Committee Votes to Withdraw Makena

After three days of discussion and several years of consideration, the FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted almost unanimously on Oct. 19, 2022, to remove Makena^® (hydroxyprogesterone caproate injection) and its generic equivalents from the U.S. market. The only drug approved to help prevent preterm birth for women who have had a preterm baby and who again are pregnant with one baby, Makena was given Accelerated Approval in 2011. Continued testing failed to show it has any effects on birth timing or complications, such as respiratory distress syndrome, sepsis, or death, for the fetus. Using it risks side effects, including blood clots that can be severe for the mother. Makena remains available until a final decision, which should be within a few months, is announced by the FDA Commissioner.

Recall
Exela Pharma Sciences recalled 49 lots of sodium bicarbonate injection, 8.4%, 50mEq/50mL, labeled as Exela or Civica, on Oct. 12, 2022. While air was being introduced before injection, some vials shattered, causing injuries to the eyes or face of the individual drawing up the solution. Sodium bicarbonate injection typically is administered by IV in a healthcare facility to manage metabolic acidosis. Exela’s notice is here.