FDA Approves TNKase To Treat Ischemic Strokes In Adults

Updated Mar 7, 2025 | 08:52 AM IST

SummaryIt is delivered as a single five-second intravenous bolus, which is faster than the standard of care Activase or alteplase, which is administered as an intravenous bolus followed by a 60-minute infusion.
Ischemic Stroke

Credits: Canva

The US Food and Drug Administration has approved TNKase or Tenecteplase, which is a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.

Ischemic strokes happen when a blood clot blocks a blood vessel in your brain. It can cause permanent brain damage and death. If enough brain cells die, you can also lose the abilities or body functions those cells control. They are also the most common types of stroke, with 80% of all strokes being ischemic strokes.

How is TNKase administered?

It is delivered as a single five-second intravenous bolus, which is faster than the standard of care Activase or alteplase, which is administered as an intravenous bolus followed by a 60-minute infusion. The manufacturer of TNKase, Genetech said a new 25-mg vial configuration will also be available in the coming months.

How Was TNKase approved?

The approval came at the backdrop of a study that compared TNKase to Activase in patients with acute ischemic stroke. These patients also presented with a disabling neurological deficit. Results show that TNKase was comparable to Activase in terms of efficacy and safety.

How Common Are These Strokes?

In the United States it self, it affects more than 795,000 people each year and is the leading cause of long-term disability. It is also the fifth leading cause of death. Since brain damage can happen if this progresses rapidly, one needs an immediate, fast-acting medical care.

TNKase thus provide a faster and simpler administration which can be critical for anyone. The chief medical officer and head of global product development at Genetech, Levi Garraway, MD., PhD., said, "Today's approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients."

What Are The Symptoms Of Ischemic Strokes?

Some of the most common symptoms include weakness or paralysis on one side of your face and body. You may also feel trouble speaking or have loss of speech, also known as aphasia. You may faced slurred or garbled speaking, also known as dysarthria. Other symptoms include loss of muscle control on one side of your face, or sudden worsening or loss of your senses, including vision, hearing, smell, taste, and touch.

Other symptoms include:

  • Loss of coordination or clumsiness
  • Blurry vision or double vision
  • Dizziness or vertigo
  • Nausea and vomiting
  • Neck stiffness
  • Mood swings or sudden personality changes
  • Confusion or agitation
  • Seizures
  • Memory loss (amnesia)
  • Headaches which are sudden and severe
  • Passing out or fainting
  • Coma

Are There Any Warning Signs?

While these are symptoms one has who is prone to this condition. However, often, many may confuse it with other illnesses. It is best to keep an eye out for warning signs. These could be looking out for yourself or your loved one. Note if there is a sudden loss of balance. Look out for sudden vision loss or changes in one or both eyes. Look for a droop on one or both sides of your face, especially when you smile. Raise both arms and see if one arm sags or drops in a way it usually does not. Note for your speech. Are you as fluent? Are you have trouble speaking? If you see any of such signs, start tracking it and talk to your healthcare provider.

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Scientists Warn Common Diabetes Drug Taken By Millions Could Cause Life-Threatening 'Diabetic Attack'

Updated Sep 2, 2026 | 01:00 PM IST

SummaryA team of Swedish researchers found that a class of common diabetes drugs increased the risk of diabetic ketoacidosis in underweight patients.
Scientists Warn Common Diabetes Drug Taken By Millions Could Cause Life-Threatening 'Diabetic Attack'

Credit: iStock

A type of common diabetes drugs prescribed to millions of diabetics has hidden, life-threatening complications, especially among those with certain risk factors.

The findings are based on a new study published in The Lancet Diabetes & Endocrinology. It studied nearly 280,000 people with type 2 diabetes treated with SGLT2 inhibitors, a class of drugs that includes dapagliflozin, empagliflozin, canagliflozin and ertugliflozin.

A research team from Karolinska Institute found that some patients were more likely to develop diabetic ketoacidosis (DKA) while taking these drugs.

The research comes after a study showed deaths from ketoacidosis are on the rise in the UK. Last year researchers from Imperial College London found ketoacidosis cases increased by a massive percentage of 81 per cent between 2015 and 2023.

What Is Diabetic Ketoacidosis And What Are Its Warning Signs?

Its symptoms can include excessive thirst, urinating frequently, stomach pain, nausea, vomiting, diarrhoea and blurred vision. More serious warning signs include deep or unusual breathing, fruity breath, extreme tiredness, sleepiness, or confusion.

Researchers said that developing an infection was the most common trigger of ketoacidosis. They also said that kidney problems, stroke and major surgery were also seen as triggers in patients who developed it.

Also read: Thailand’s HIV Cases Cross 550,000 In 2026; Over 25,000 Among 15–24s

What Are The Study's Findings?

SGLT2 inhibitors reduce blood sugar by helping the kidneys remove excess glucose through urine. They are widely used in type 2 diabetes treatment as their benefits extend to the heart and kidneys as well. Some studies have also linked them to weight loss.

However, these medicines can encourage the body to rely more heavily on fat for energy. This process can increase ketone production, increasing the risk of ketoacidosis in susceptible patients.

The study found that the risk was particularly high among people who had previously experienced ketoacidosis, had high blood sugar, were underweight, or showed signs of malnutrition.

Patients with a history of dangerously low blood sugar (hypoglycaemia) were also at increased risk.

Also read: Once-Weekly Oral Combination HIV Pill Shows Promise As Alternative to Daily Treatment

Greater Risk At The Beginning Of The Treatment

While patients faced their greatest risk during the first few months after starting an SGLT2 inhibitor, researchers found that the risk persisted for as long as they continued taking the medicine.

This finding is contradictory to previous research that has largely focused on ketoacidosis occurring soon after treatment begins.

Peter Ueda, assistant professor at the Department of Medicine at the Karolinska Institute, said the findings should not be interpreted as a reason for patients to stop their medication.

SGLT2 inhibitors provide medical benefits for many patients,” Ueda said.“Our findings are not primarily about avoiding treatment, but about improving our ability to identify high-risk patients and use these medicines more safely,” he added.

The findings can help doctors identify people who may need closer monitoring before and during treatment, particularly if they have previous ketoacidosis, are underweight or malnourished, or develop an infection.

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Thailand’s HIV Cases Cross 550,000 In 2026; Over 25,000 Among 15–24s

Updated Sep 2, 2026 | 01:08 PM IST

Summary​More than 83% of people receiving HIV care are on continuous antiretroviral treatment in the country, and have achieved effective viral suppression, reducing the risk of serious illness and onward transmission, the media report said.
Thailand’s HIV Cases Cross 550,000 In 2026; Over 25,000 Among 15–24s

Credit: iStock

Thailand has recorded 557,993 cumulative HIV cases in 2026, according to health authorities, who said the number of new infections has fallen by 12,000 over the past three years.

Thirteen of Thailand’s 77 provinces now record more than 10,000 cases each, Bangkok Post reported.

Regions Affected

The Central region bears the highest HIV burden, with several provinces reporting more than 10,000 cumulative cases:

  • Bangkok: 88,535 cumulative HIV cases — the highest in Thailand.
  • Chonburi: 31,072 cases.
  • Chiang Mai: 23,949 cases.
  • Chiang Rai: 17,524 cases.
  • Other provinces with over 10,000 cases: Nakhon Ratchasima, Samut Prakan, Nonthaburi, Khon Kaen, Pathum Thani, Udon Thani, Rayong, Songkhla and Ubon Ratchathani.
  • Songkhla: 10,644 cumulative cases, the highest in Health Region 12, according to the Office of Disease Prevention and Control Region 12.

Youths at High Risk

Young people aged 15 to 24 are a particular concern, accounting for more than 25,000 cumulative cases, the report said.

Officials said infections in the region were concentrated among young people and the working-age population, with unprotected sex remaining a major factor.

HIV Treatment

More than 83% of people receiving HIV care are on continuous antiretroviral treatment in the country, and have achieved effective viral suppression, reducing the risk of serious illness and onward transmission, the report said.

Why New Infections Remain a Concern

Speaking to local media, Associate Professor Dr. Opas Putcharoen, Deputy Director of the AIDS and Infectious Diseases Research Center at the Thai Red Cross, said new cases will continue to rise in the country due to increased testing, which identifies nearly 60,000 people who are unaware they are infected, combined with an estimated 8,000–9,000 new cases annually.

The most concerning and critical group is youth aged 15–24. The reason new infections have not decreased is insufficient knowledge about HIV and AIDS, Thairath Online reported.

He noted that many people underestimate their risk and therefore do not protect themselves. He stressed the urgency of campaigns encouraging people to know their HIV status so those who test positive can start treatment and reduce transmission.

Health officials said more efforts were needed to expand access to testing, encourage consistent condom use and ensure people living with HIV remain on antiretroviral treatment.

They said early diagnosis and continued treatment reduce infections and improve the long-term health of people living with HIV.

What Is HIV?

HIV (human immunodeficiency virus) attacks the body's immune system, increasing the chances of developing serious infections or cancer.

The virus specifically targets CD4 cells, which are crucial for the body’s defence against infections. As HIV progresses, it destroys these cells, weakening the immune system over time. If left untreated, this continuous damage can lead to AIDS.

There is no cure for HIV, but prevention and treatment options are available.

For HIV, the primary treatment goal is to suppress the virus to undetectable levels, thus maintaining a strong immune system and preventing further transmission of the virus. People living with HIV can often live long, healthy lives if they adhere to ART.

How To Stay Safe?

According to UNAIDS, HIV risk can be effectively prevented by combining barrier methods, antiretroviral medications, and harm reduction strategies. Key prevention methods include:

  • Use Condoms
  • Using Pre-Exposure Prophylaxis (PrEP)
  • Post-Exposure Prophylaxis (PEP): Emergency antiretroviral medication must be started within 72 hours of a possible HIV exposure to stop the infection.
  • Avoid sharing needles, syringes, or other injection and sharp equipment, and use sterile instruments for any medical or body-modification procedures.

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Once-Weekly Oral Combination HIV Pill Shows Promise As Alternative to Daily Treatment

Updated Sep 2, 2026 | 10:22 AM IST

SummaryThe weekly tablet combines two long-acting antiretroviral medicines — Merck’s islatravir and Gilead Sciences’ lenacapavir. Both drugs are US FDA-approved, but their combination is not.
Once-Weekly Oral Combination HIV Pill Shows Promise As Alternative to Daily Treatment

Credit: iStock

A once-weekly oral HIV combination therapy may offer an effective alternative to standard daily treatment, according to results from a global phase 3 clinical trial.

The weekly tablet combines two long-acting antiretroviral medicines — Merck’s islatravir and Gilead Scienceslenacapavir — with complementary mechanisms of action that enable once-weekly dosing. The combination could reduce the burden of lifelong daily pill-taking for people living with HIV, revealed the trial published in the New England Journal of Medicine last week.

What Did The New Trial Show?

The randomized, double-blind trial evaluated a once-weekly combination tablet containing islatravir and lenacapavir in adults whose HIV had remained suppressed for at least six months while taking the daily regimen bictegravir–emtricitabine–tenofovir alafenamide by Gilead.

The international study involved 607 adults across 106 clinical sites in 12 countries. Participants who had maintained viral suppression on standard daily treatment were randomly assigned either to switch to the once-weekly tablet or remain on their existing daily medication.

After 48 weeks, the once-weekly regimen proved non-inferior to the standard once-daily treatment. Overall, 93.4% of participants taking the weekly regimen and 92.4% of those continuing daily therapy maintained viral suppression.

No participants receiving the weekly treatment experienced virological failure. At week 48, no participants taking the once-weekly regimen had a viral load of 50 copies per milliliter or higher, compared with one participant (0.3%) in the daily-treatment group.

None of the participants developed resistance to either islatravir or lenacapavir.

CD4+ T-Cell Levels Remained Stable

Levels of CD4+ T-cells and total lymphocytes, which are immune cells that help fight infections, remained stable in both groups.

Earlier studies of higher daily doses of islatravir raised concerns about declines in immune cell counts.

Comparable Safety Profile

About 80% of participants in each group experienced at least one mild or moderate adverse event, such as headache or diarrhea.

Serious adverse events were less common, occurring in 16 participants (5.3%) receiving the weekly regimen and 14 participants (4.6%) receiving daily therapy.

Six participants in the weekly regimen group and five in the daily-treatment group discontinued treatment due to adverse events. No deaths were reported.

“As such, these findings support the safety of the current weekly 2-mg [milligram] dose of islatravir,” the researchers wrote in the paper.

Both Drugs Are FDA-approved

Both islatravir and lenacapavir are US FDA-approved, but their combination is not.

Islatravir is approved by the FDA in combination with doravirine and is marketed as Idvynso. It is prescribed as a daily oral treatment for virologically suppressed adults.

Lenacapavir is also approved by the FDA as a multi-drug component for treatment-resistant HIV, marketed as Sunlenca. It is also approved as a twice-yearly injection for HIV prevention or PrEP, marketed as Yeztugo.

The study remains ongoing and participants will continue to be followed for a total of 96 weeks to assess longer-term safety and effectiveness.

Could Reduce ‘Pill Fatigue’

The researchers said that the once-weekly oral regimen could also help address “pill fatigue,” or the mental and emotional burden of taking medication every day.

For some patients, a weekly oral regimen may be more convenient than long-acting injectable HIV therapies, which require regular clinic visits.

“The first ever weekly oral therapy for the treatment of HIV could offer welcome relief from the burden of life-long daily pill-taking for people living with HIV. This is especially important for people that are experiencing stigma and people with other HIV-associated health conditions who are taking multiple other tablets,” said Professor Chloe Orkin MBE, Professor of Infection and Inequities and Dean for Healthcare Transformation at Queen Mary University of London.

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