EAU given for Remdesivir for Infants? SHOCKING FDA MEMORANDUM

Emergency Use Authorization (EUA) for remdesivir, an unapproved product Center for Drug Evaluation and Research (CDER) Memorandum

HOW DID THEY RATIONALIZE GIVING THIS DRUG TO INFANTS

1. MODELS AND SIMULATIONS (LIKE CLIMATE CHANGE. THIS IS AL GORE IN PHARMA)

2. PREDICTED TO BE SIMILAR TO CERTAIN SPECIFIC ADULT STUDIES;

3. Expectations that DATA ON ADULTS will be the same, and ‘extrapolations’

   Phew! that should work for those babies.

“Rationale for Dose in Pediatrics:

The recommended dose for RDV for use in non-hospitalized pediatric patients with mild-to-moderate COVID-19 was based on the following:

• Based on pharmacokinetic modeling and simulation, exposures in pediatric patients after administration of the authorized pediatric dose(s) are expected to be comparable to the exposures observed in adults after administration of the authorized adult dose(s).

• The recommended dosing in hospitalized and non-hospitalized adult and pediatric patients for the approved product is the same except for the duration of therapy (5-10 days for hospitalized and 3 days for nonhospitalized). Therefore, the same principle was used for the pediatric patients 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg. The same dosing under the EUA for hospitalized pediatric patients was used for the revised EUA for non hospitalized pediatric patients except for the duration (5-10 days for hospitalized and 3 days for non-hospitalized).

• Robust clinical data are available in hospitalized and non-hospitalized adults. Because exposures in pediatric patients are expected to be comparable to the exposures observed in adults, the EUA revision for non-hospitalized pediatric patients with mild-to-moderate COVID-19 is supported through extrapolation of efficacy from adequate and well-controlled studies in adults. “

and now we get to the REASONABLE TO BELIEVE APPROVAL SECTION AND RISK BENEFIT SECTION

“VI. Risk-Benefit Assessment and Recommendations for Emergency Use Based on the totality of scientific evidence available, it is reasonable to believe that Veklury may be effective for the treatment of COVID-19 in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg, with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, and that, the known and potential benefits of Veklury, when administered for the treatment of COVID-19 as described above, outweigh the known and potential risks of the product.”

REASONABLE TO BELIEVE IT MAY BE EFFECTIVE. AND MAY BE SAFE FOR INFANTS.

BASED ON CLIMATE CHANGE LIKE MODELS. * my designation. not theirs. Interpret differently. Go ahead.

“Although the available data have limitations, it is plausible that the impact of a direct-acting antiviral drug (such as remdesivir) for the treatment of COVID-19 may be greater if administered earlier in the disease course when viral replication, as opposed to immunopathological processes, may be playing a greater role.

FDA has determined that expanding this authorized use is appropriate to protect public health or safety under section 564(g)(2) of the Federal Food, Drug and Cosmetic Act. The Agency believes that expanding the EUA will ensure that important information about the recommended use (e.g., dosing recommendations) for pediatric patients not covered under the USPI will continue to be available to health care providers. As noted above, FDA will revise the EUA concurrent with the approval of NDA 214787/S-10.”

warnings though

Warnings

There are limited clinical data available for VEKLURY in pediatric patients

weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age

weighing at least 3.5 kg. Serious and unexpected adverse events may occur that

have not been previously reported with VEKLURY use.

Hypersensitivity Including Infusion-Related and Anaphylactic Reactions

Hypersensitivity reactions, including infusion-related and anaphylactic reactions,

have been observed during and following administration of VEKLURY; most

occurred within one hour. Signs and symptoms may include hypotension,

hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing,

angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates,

with a maximum infusion time of up to 120 minutes, can be considered to

potentially prevent these signs and symptoms. Monitor patients during infusion

and observe patients for at least one hour after infusion is complete for signs and

symptoms of hypersensitivity as clinically appropriate. If signs and symptoms of a

clinically significant hypersensitivity reaction occur, immediately discontinue

administration of VEKLURY and initiate appropriate treatment. The use of

VEKLURY is contraindicated in patients with known hypersensitivity to VEKLURY

or any components of the product [see Full EUA Prescribing Information,

Contraindications (4), Warnings and Precautions (5.1)].

Increased Risk of Transaminase Elevations

Transaminase elevations have been observed in healthy volunteers who

received 200 mg of VEKLURY followed by 100 mg doses up to 10 days; the

transaminase elevations were mild (Grade 1) to moderate (Grade 2) in severity

and resolved upon discontinuation of VEKLURY. Transaminase elevations have

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Reference ID: 4924711

also been reported in patients with COVID-19 who received VEKLURY. Because

transaminase elevations have been reported as a clinical feature of COVID-19,

and the incidence was similar in patients receiving placebo versus VEKLURY in

clinical trials of VEKLURY, discerning the contribution of VEKLURY to

transaminase elevations in patients with COVID-19 can be challenging [see Full

EUA Prescribing Information, Warnings and Precautions (5.2)].

Perform hepatic laboratory testing in all patients before starting VEKLURY and

during treatment as clinically appropriate.

• Consider discontinuing VEKLURY if ALT levels increase to greater than

10 times the upper limit of normal.

• Discontinue VEKLURY if ALT elevation is accompanied by signs or

symptoms of liver inflammation.

Risk of Reduced Antiviral Activity When Coadministered with Chloroquine

Phosphate or Hydroxychloroquine Sulfate

Coadministration of VEKLURY and chloroquine phosphate or

hydroxychloroquine sulfate is not recommended based on data from cell

culture experiments demonstrating a potential antagonistic effect of chloroquine

on the intracellular metabolic activation and antiviral activity of VEKLURY [see

Full EUA Prescribing Information, Warnings and Precautions (5.3), Drug

Interactions (10), Microbiology/Resistance Information (15)].

Serious Side Effects

Serious adverse reactions have been associated with VEKLURY [see Full EUA

Prescribing Information, Overall Safety Summary (6.1)].

Additional serious adverse reactions associated with the drug may become

apparent with more widespread use.”

WHO SIGNED THIS FOR BABIES?

This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record. /s/

SAEBYEOL JANG 01/21/2022 03:57:30 PM

KIMBERLY A STRUBLE 01/21/2022 04:00:21 PM

YODIT BELEW 01/21/2022 04:04:09 PM

JOHN J FARLEY 01/21/2022 04:07:04 PM

for you: here is the whole Memorandum downloaded

Eua Review Eua000046 01 21 2022 Redacted

1.77MB ∙ PDF file

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Please share and review. How do you feel about EAU approved products for infants?

Shitty?

Ya. Me too.