Leronlimab is reportedly giving promising results in the quest for Covid-19 treatments, but pharmaceutical firms appear to be standing on its way for approval for mass production and use against patients infected with coronavirus.
How does Leronlimab work on Covid-19? Very simply, it is thought to reduce the amount of inflammation in the lungs caused by coronavirus, so it may help with breathing problems by freeing air passage.
ARE big pharmaceutical firms blocking the approval of Leronlimab as treatment against severe cases of Covid-19 infections?
If Leronlimab is said to decrease mortality by 82% among critically ill Covid-19 patients – why is it not used widely?
As it is, the drug is humanized IgG4 monoclonal antibody (mAb) and belongs to a group of medicine that are CCR5 antagonists.
Leronlimab is an investigational drug currently being studied for the treatment of HIV infection as well as cancer.
In the past eight years, Leronlimab has not had one adverse reaction and is considered a safe treatment.
However, the US Food and Drug Administration continues to pose roadblocks as it tries to get approval for widespread use.
Big pharmas
It is widely believed by industry observers that if the drug is approved, big pharmaceutical companies will lose billions of dollars as Leronlimab will eliminate the need for other medication.
Given this fact, there has been constant attempts through the years to make it impossible for the drug to be approved for widespread use.
After all, the biopharmaceutical industry is responsible for providing the FDA with 75 percent of its funding for drug reviews.
This means that for them not to lose funding, they must continue to turn a blind eye to Leronlimab despite its success in treating illnesses such as HIV, cancer, and now, COVID-19.
Erap’s case
Recently, it was reported by former Senator Jinggoy Estrada that his 84-year-old father, former President Joseph Ejercito Estrada, was treated with Leronlimab after he contracted Covid-19.
Although Mr. Estrada refuses to give full credit to Leronlimab for the recovery of President Erap, research can back that claim.
Research has shown that Leronlimab decreases mortality by up to 82 percent among critically-ill Covid-19 patients after two weeks.
Patients who received Leronlimab were 5x more likely to be alive at the end of day 14 than those who received standard hospital care.
400 percent improvement
Critically-ill Covid-19 patients are those receiving invasive mechanical ventilation (IMV).
The administration of the drug also showed a 400% improvement in ranking on the 7-point ordinal scale used to measure clinical status in conjunction to standard care of critically-ill patients.
For the select few who were given the go signal to use the drug in the treatment of Covid-19, it has worked wonders – but what about the ordinary citizens who do not have access to this drug?
Compassionate use
In the Philippines, the Food and Drug Administration granted a compassionate special permit (CSP) to two doctors for the use of Leronlimab to treat two COVID-19 patients.
However, they refused to say who these patients were to protect their privacy.
According to the FDA, only institutions or doctors in charge of patients being treated are allowed to request for a CSP. These doctors and institutions should also take full responsibility for the use of Leronlimab.
On top of this, doctors should inform patients that the drug is currently in the investigational status, and that the doctors need to provide a report of the outcomes for each patient given the product.
Evidence-backed data
Although the drug has been administered to two patients, one seemingly being President Estrada, its widespread administration could help save thousands of lives.
Although the FDA is working towards giving the rest of the country access to it, the agency revealed that it cannot replace the current prescribed drug registration process, as it involves a systematic evaluation of evidence-backed data.
Granting CSPs is also not equivalent to a Certificate of Product Registration or Emergency Use Authorization, as the agency cannot assure the product’s safety, quality, and efficacy. Given this fact, leronlimab cannot be marketed commercially.
Supplemental drug
Big pharmaceutical companies would definitely discount using Leronlimab as an effective drug against Covid-19, especially since it would diminish the need for their own medicine.
However, what people don’t seem to realize is that Leronlimab works best when supported with other commonly used Covid-19 treatments such as dexamethasone.
Therefore, if these companies put aside their own greed, their products may actually be used to supplement Leronlimab, and this combination could easily save thousands of lives infected by Covid-19.
Should the Philippine FDA approve the use of Leronlimab, the government’s woes will decrease significantly, and the country may start to see improvement in its Covid-19 trends and the worsening situation in the country’s healthcare centers and hospitals. (OM)
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