FDA Drug Approvals

• FDA approves Keytruda Qlex, a subcutaneous injection version of the widely used cancer therapy Keytruda

• Patients can now receive treatment in as little as one to two minutes, compared to a 30-minute IV infusion

• New option offers greater convenience and flexibility in treatment settings, from hospitals to local clinics

The U.S. Food and Drug Administration (FDA) has approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), a new subcutaneous form of Merck’s flagship cancer immunotherapy Keytruda. This marks the first time patients across most of Keytruda’s 38 cancer indications will have access to the drug in an injection form rather than an intravenous (IV) infusion.

Keytruda Qlex can be administered by a healthcare provider in just one minute every three weeks or two minutes every six weeks. That’s a major time savings compared to the 30-minute IV infusion required for traditional Keytruda.

“This approval is significant for patients and health care providers like me who have been using immunotherapies for years to treat certain cancers,” said Dr. J. Thaddeus Beck, oncologist and medical director of the Highlands’ Clinical Trials Office. “Subcutaneous pembrolizumab provides faster administration, two dosing options, and more choices for where patients can receive care.”

Comparable effectiveness and safety

In pivotal clinical trials, Keytruda Qlex showed similar effectiveness and safety compared to IV Keytruda. Patients with advanced lung cancer who received the injection saw response rates and survival outcomes nearly identical to those receiving the infusion.

The new formulation was developed with the help of biotechnology company Alteogen Inc., whose enzyme allows pembrolizumab to be delivered under the skin instead of through a vein.

For patients who struggle with vein access or who don’t have a port in place, the subcutaneous injection may simplify treatment. It also gives patients and providers more flexibility in choosing where treatment takes place, whether in a hospital infusion center, a doctor’s office, or a community clinic.

“This is about giving patients options and helping them manage treatment in a way that best fits their needs,” said Dr. Marjorie Green, senior vice president and head of oncology at Merck Research Laboratories.

Safety considerations

As with IV Keytruda, Keytruda Qlex carries risks of serious immune-related side effects, which may affect organs such as the lungs, liver, or kidneys, and in rare cases can be life-threatening. 

It is not recommended for certain patients, including those with hypersensitivity to its components or pregnant women due to potential risks to the fetus. Patients are encouraged to discuss the benefits and risks with their healthcare team.

Merck expects Keytruda Qlex to be available in the United States in late September. Patients and caregivers can ask their oncologists if the new injection option is right for them.

Johnson & Johnson has announced that the U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray as the first and only monotherapy for adults with major depressive disorder who have not responded adequately to at least two oral antidepressants. 

The company hailed the approval as “a significant advancement in the treatment of MDD,” a condition affecting approximately 21 million adults in the United States.

Major depressive disorder is one of the most prevalent psychiatric disorders, and about one-third of patients do not respond to traditional oral antidepressants, severely impacting the quality of life and contributing to the high economic burden associated with treatment-resistant depression.

Image below via Johnson & Johnson

Complicated treatment

"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” said Bill Martin, head of Neuroscience at Johnson & Johnson Innovative Medicine.  

“Spravato is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral antidepressants."

The FDA's decision followed a priority review and was based on positive outcomes from a randomized, double-blind, placebo-controlled study.

Johnson & Johnson said the study demonstrated that Spravato significantly improved depressive symptoms compared to placebo, with 22.5% of patients achieving remission at week four, compared to 7.6% in the placebo group. The safety profile of SPRAVATO® was consistent with previous data, with no new safety concerns identified.

The new drug is available only through a restricted program known as the Spravato Risk Evaluation and Mitigation Strategy Program. 

Zepbound is Eli Lilly’s weight loss drug. Now, it is also a drug to treat obstructive sleep apnea (OSA).

The U.S. Food and Drug Administration has approved Zepbound (tirzepatide) as the first drug treatment for adults with moderate to severe OSA who also have obesity. The FDA said the approval marks a significant advancement in the management of a condition that affects millions of individuals, particularly those struggling with obesity.

Dr. Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said the approval “is a major step forward for patients with obstructive sleep apnea.”

Obstructive sleep apnea is characterized by repeated interruptions in breathing during sleep due to the blockage of the upper airway. While continuous positive airway pressure (CPAP) devices have been the standard treatment, many patients find them uncomfortable or difficult to use consistently. 

A new approach to an old problem

The FDA said Zepbound offers a new pharmacological approach by activating receptors of hormones secreted from the intestine, specifically glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), to reduce appetite and food intake, thereby promoting weight loss and improving OSA symptoms.

The FDA said its approval is based on the results of two pivotal randomized, double-blind, placebo-controlled studies involving 469 adults without type 2 diabetes. These studies demonstrated that participants receiving Zepbound experienced a significant reduction in the apnea-hypopnea index (AHI), a key measure of OSA severity, compared to those receiving a placebo. 

The studies also showed that a greater proportion of participants treated with Zepbound achieved remission or mild OSA, alongside significant weight loss.

Potential side effects

The FDA cautions that Zepbound is not without potential side effects. Common adverse reactions include gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort, as well as injection site reactions and fatigue. 

More serious concerns include the risk of thyroid C-cell tumors, pancreatitis, gallbladder problems, and hypoglycemia, particularly when used with insulin or insulin-secreting medications. Consequently, Zepbound is contraindicated in patients with a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2.

The FDA said patients considering Zepbound should engage in thorough discussions with their healthcare providers to weigh the benefits against potential risks, especially if they have pre-existing conditions such as kidney disease, diabetic retinopathy, or a history of depression or suicidal thoughts. 

Buy-herbal.com has issued a recall of all lots within current expiration dates of Nhan Sam Tuyet Lien Truy Phong Hoan capsules. A Food and Drug Administration analysis has found these products to contain undeclared furosemide, dexamethasone and chlorpheniramine. 

Furosemide was found at 5.24 mg/g or 1.84 mg/capsule. Dexamethasone was found at 2.22 mg/g or 0.780 mg/capsule. Chlorpheniramine was found at 4.38 mg/g or 1.54 mg/capsule. 

Products containing these drugs cannot be marketed as dietary supplements. The FDA said Nhan Sam Tuyet Lien Truy Phong Hoan Capsules is an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

What to do

Buy-herbal.com is notifying its customers via email who have bought the product on buy-herbal.com to return for a refund of the recalled product.

Consumers who have Nhan Sam Tuyet Lien Truy Phong Hoan subject to recall should stop using the product and contact info@buy-herbal.com for return and refund. Please ship the recalled products to 136-61 41st Ave, Box # 248, Flushing, NY 11355 and contact info@buy-herbal.com for refunds.

Consumers with questions regarding this recall can email info@buy-herbal.com or call 917 495 6088 on Monday through Friday from 10 am till 6 pm Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers can contact info@buy-herbal.com for return and refunds.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

If you recently got a tattoo, a piercing, a laser treatment, or are thinking about getting one, you might want to consider one of a large yellow “Danger” sign.

The Food and Drug Administration (FDA) is warning consumers that the numbing creams you see online for those procedures often have too much  lidocaine, which might make your skin crawl in a whole different way.

The agency’s concern about lidocaine is that the cream’s concentrations are higher than what is permitted for over-the-counter, topical pain relief products. 

“When these products that contain high concentrations of lidocaine intended to be used before or during certain cosmetic procedures are applied in ways that could lead to increased absorption of the drug product through the skin, it may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties," the agency said. "These products may also interact with medications or dietary supplements a consumer is taking."

The FDA isn’t playing around with this situation, either. In letters to six different companies -- such as this one to the manufacturer of NumbSkin -- the agency told these manufacturers that these products are in violation of federal law.

How to stay comfortably numb

The agency says that anyone who needs a “numbing product” would be wise to:

• Check the label: Never use anything over-the-counter with more than 4% lidocaine.

• Less is more: Don't slather it on huge areas of your skin, especially if your skin's already irritated.

• No plastic wrap: Don't cover the area with plastic wrap or anything that traps the cream.

And if you have any bad side effects from these creams, be sure to tell the FDA ASAP through its MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products.