Enhances both innate & adaptive immunity and strengthens body’s immune response to viral infections
March 5: In a landmark development for the treatment of COVID-19, Themis Medicare Ltd. (Themis), a Pharmaceutical company headquartered in Mumbai with a legacy of over 50 years of making new treatment options available, announced the approval of its antiviral drug VIRALEX® by the Drug Controller General of India (DCGI). As per the results of a double-blind randomized controlled trials (RCT), the drug helps in early relief of the clinical symptoms in mild tomoderateCOVID-19 patients.
Viralex® has been found to be effective and well tolerated in mild to moderate COVID-19, in two Randomized Controlled Clinical Trials conducted on 499 Indian patients.
In line with the DCGI’s current approach for approval of medicines for the management of the ongoing pandemic, approval for VIRALEX® (Generic name: Inosinepranobex) is based on the results of the robust phase 2 and phase 3RCTs conducted in India, and the well-established safety profile of the drug.
As per the results of the Phase 3 Randomized, Double-blind, Placebo-controlled Trial, 80.17% of patients treated with VIRALEX® showed clinical improvement on day 6, which is significantly higher (p<0.001) from that in the controlled group.
(52.38%) among the mild to moderate non-hospitalized COVID-19 patients. Clinical Cure was also significantly higher in the VIRALEX® group as compared to that in the placebo group on day 6 of treatment. There was early improvement and cure from symptoms in patients who received VIRALEX®. This drug was well tolerated by the patients without any serious side effects. The study was conducted during the Delta wave of the pandemic.
Randomized, Double-Blind, Placebo-controlled, Multicentre Trial is considered as the clinical research methodology of the highest global standard for evaluating drugs against diseases. Themis is one of the few companies to submit data from a higher number of patients from RCTs for approval in management of COVID-19.
After detailed deliberation, the drug regulatory authority granted permission to manufacture and market this new drug for restricted emergency use of the drug as an add on therapy for treatment of mild and moderate COVID-19.
VIRALEX® would be available on the prescription.
Based on the promising study results, the drug appears to offer immense clinical benefit to the patients in the early stages of COVID-19, thus reducing the load on the healthcare system.
VIRALEX® is an immune modulatory agent with broad-spectrum antiviral properties. It enhances both innate & adaptive immunity and strengthens the body’s defence response to viral infections. In an invitro study initiated by Themis, it showed dose-dependent inhibition of viral replication against SARS-CoV-2 (COVID-19).
According to Themis, VIRALEX® will be manufactured at an EU-GMP-certified facility with the highest safety standards and stringent manufacturing protocols in place, and the medication will be available in the form of a 500 mg tablet at a much affordable price.
Speaking at the release, Dr. Sachin Patel, Managing Director & CEO of Themis Medicare Ltd. said, “Our endeavor has always been to develop medicines that benefit patients and make healthcare far, far more effective. Given the current scenario of grave health concerns and economic challenges surrounding COVID-19 in India, this is our effort to contribute to the well being of people of India”.
“Due to the frequently mutating trend of the virus, the uncertainties of the pandemic continue. We hope access to effective treatment such as VIRALEX® will offer a much-needed therapeutic solution, and if initiated early in the disease, it would reduce the load on the healthcare system.”
Commenting on the significance of this development, Dr. Ashok Swain, Head Clinical Development, congratulated the entire Themis Medicare Ltd. team for achieving an important milestone of adding this effective medicine with an established safety profile to address the unmet need in the management of the pandemic.
“VIRALEX® is a new ray of hope in these challenging times,” he said.
Dr Raja Dhar, eminent pulmonologist and Director and Head of Department of Pulmonology, C K Birla Hospitals, said “Inosine Pranobexisa drug which enhances host immunity (immune modulatory effect) and can affect viral RNA and hence inhibits growth of several viruses. Phase 3 Double blind RCTs are rarein COVID 19. I am heartened to hear that Themis Medicare has come up with such a trial, which shows early clinical response and shortened period of recovery when used in mild to moderate COVID19 cases. This drug, if successfully used in clinical practice would considerably reduce the burden on healthcare system.
Dr Dhar is also the current Chair of Training and Education Initiatives, Indian Chest Society, and Director of Research and Training, National Allergy Asthma Bronchitis Institute.
With a strong R&D backup, skilled domestic & export teams, and 4 state-of-the-art manufacturing sites, the endeavour at Themis has always been to support the medical fraternity with solutions for major unmet medical needs like VIRALEX® for COVID-19…and still counting!
About Themis Medicare Ltd
Themis Medicare was incorporated in 1969 as a joint venture partnership at Vapi. Today, it is one of the fastest growing pharma Company specializing in the development of complex molecules. With strong research focus on injectables, complex generic products and drug-delivery systems, the Company has evolved in to being a formidable layer in the complex generics space.
It has a diversified business model with presence across the B2B model and strong presence in domestic B2C market. The Company also has a significant export presence in the RoW geographies. The qualified and experienced Management team is complemented by highly skilled R&D workforce. The Company has three vertically integrated manufacturing facilities, of which two are focused on developing APIs–1 each involved in manufacturing Synthetic API and Fermentation based API, and 1 is involved in manufacturing of Finished Dosage Formulations. Themis offers products in various dosage forms in multiple therapeutics areas with leadership in Pain Management and Critical Care. The Company has a strategy to focus and grow its injectables portfolio and develop its NDDS presence.
For more details, please visit: www.themismedicare.com
39 thoughts on “DCGI approves Themis Medicare’s VIRALEX® for Covid-19 treatment”
Receive and send emails through your temporary messaging system. Use our webmail or your favorite email software with our absolutely free disposable email. temp mail
585496 412386Absolutely nothing much better than Bing finding us a very good web site related to what I was seeking for. 527953
580799 5018Great V I should definitely pronounce, impressed with your web site. I had no trouble navigating through all the tabs and related info ended up being truly simple to do to access. I recently found what I hoped for before you know it in the least. 429628
139497 756344I discovered your blog website web site on google and appearance some of your early posts. Preserve up the excellent operate. I just extra increase Feed to my MSN News Reader. Looking for toward reading far more by you later on! 423562
279020 621301I recognize there exists a fantastic deal of spam on this blog internet site. Do you need help cleaning them up? I can support among courses! 60036
475649 824176There is noticeably a bundle to know about this. I assume you made certain good points in features also 176014
146492 842859Its great as your other blog posts : D, thanks for posting . 685513
716039 688842Definitely composed written content material , thanks for information . 381080
I loved as much as you will receive carried out right here. The sketch is attractive, your authored material stylish. nonetheless, you command get bought an shakiness over that you wish be delivering the following. unwell unquestionably come more formerly again as exactly the same nearly a lot often inside case you shield this hike.
You are a very capable individual!
I have been exploring for a bit for any high quality articles or blog posts on this kind of area . Exploring in Yahoo I at last stumbled upon this web site. Reading this information So i’m happy to convey that I have a very good uncanny feeling I discovered exactly what I needed. I most certainly will make sure to do not forget this web site and give it a glance regularly.
Wow, marvelous weblog format! How lengthy have you been blogging for? you make running a blog glance easy. The total glance of your website is magnificent, let alone the content material!
Hi my family member! I want to say that this article is amazing, great written and include approximately all vital infos. I would like to peer more posts like this .
Woah! I’m really enjoying the template/theme of this website. It’s simple, yet effective. A lot of times it’s challenging to get that “perfect balance” between superb usability and appearance. I must say that you’ve done a fantastic job with this. Also, the blog loads extremely fast for me on Internet explorer. Outstanding Blog!
Maravilha poder usufruir deste conteúdo neste site. Também temos conteúdos relacionados com este em nosso site. Basta acesssar nosso link!
734233 283244Hello! Ive been following your blog for a although now and lastly got the courage to go ahead and give you a shout out from Kingwood Texas! Just wanted to mention keep up the good function! 208801
nolvadex cream Watch this video to learn about antral follicle counts and see how we do the test
generic propecia Digoxin Lanoxin and Azole Antifungals
combivir metronidazole injeksi dosis Let s face it, that No tamoxifen wiki
The eluent was detected using UV detector at 246 nm clomid donde puedo comprar She was waiting an hour and a half between waking and eating, which is not a good thing
clomid 25 mg testosterone Eighty four women were postmenopausal patients who participated in a randomized trial testing tamoxifen as an adjuvant to postmastectomy radiotherapy
Unfortunately, this clinic s office staff were not as efficient as the Doctor or nurses best price cialis 20mg Alcohol and neurotransmitter interactions
892510 904965This plot doesnt reveal itself; it has to be explained. 646172
These genes were then used to develop an outcome predictor on a training set of 65 luminal breast cancers and then validated on three independent published data sets does viagra always work French maritime pine bark extract and rutosides have demonstrated inconsistent results
1 Patient Caregiver Instructions what does clomid do
stromectol bed bugs Interestingly, we observed that GLP 1 4 Ојg kg, s
Quick facts about asking for 2 priligy 30mg price The compound of any one of embodiments 1 7 wherein R 7A is C 1 6 aliphatic
is lasix a blood thinner Uvula edema usually manifests as fullness of the oropharynx and difficulty in talking
black viagra pills review carbidopa para que serve ciprofibrato de 100 miligramas Mr
Under normal circumstances, Huang Lei could not be Huang Qing is opponent at all buy zithromax z pak
net share symptoms that you may have azithromycin online
It is, however, impossible to predict which postmenopausal breast cancer patient will develop adenomyosis after treatment with TAM cialis prices 5mg, 5mg, 10mg and 20mg pills
buy zithromax canada online In contrast, a nonplanar oestrogen binds in the ligand binding domain, but prevents activation of AF 2
I believe you have noted some very interesting points, thanks for the post.
675527 265940Im often to blogging and i in actual fact respect your content. The piece has really peaks my interest. Im going to bookmark your content material and preserve checking for brand new information. 627959
He says first full day of AF counts as CD1 so that would be yesterday so if I start clomid on Wed that would be CD4 buy cialis online forum Cyclosporine levels may be reduced by sulfonamides
Hello just wanted to give you a quick heads up. The text in your article seem to be running off the screen in Firefox. I’m not sure if this is a formatting issue or something to do with web browser compatibility but I figured I’d post to let you know. The layout look great though! Hope you get the problem fixed soon. Thanks
Hi there! I know this is kinda off topic however I’d figured I’d ask. Would you be interested in exchanging links or maybe guest authoring a blog post or vice-versa? My site goes over a lot of the same topics as yours and I believe we could greatly benefit from each other. If you are interested feel free to send me an email. I look forward to hearing from you! Great blog by the way!
Really good visual appeal on this web site, I’d value it 10 10.