Glenmark's FabiFlu approved for COVID-19 treatment in India; priced at Rs 103 a tablet
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New Delhi: Drug major Glenmark Pharmaceuticals has become the first Indian company to commercially launch an antiviral drug - Favipiravir with brand name FabiFlu - for the treatment of mild to moderate COVID-19 patients. The company received marketing and manufacturing approval from the Indian drug regulator, Drug Controller General of India (DCGI), and launched the product in the Indian market today.
Priced at Rs 3,500 for a pack of 34 tablets (Rs 103 per tablet), the dosage is 200 mg X 9 tablets on day one and 200 mg X 4 tablets a day for 14 days of the treatment. Glenmark did a clinical trial among 90 mild and 60 moderate COVID-19 patients across 11 sites in India. The drug is claimed to have an efficacy of over 80% in the treatment of COVID-19 mild to moderate patients.
Sources said Delhi-based Brinton Pharmaceuticals, Bengaluru-based Strides Pharma, Mumbai-based Lasa Supergenerics, Hyderabad-based Optimus Pharma are some of the other Indian firms that have applied for approval and are readying its launch in India.
Glenmark had developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through in-house R&D. The DCGI allowed fast track trials with Phase III in limited patients. The approval process is also under Emergency Use Authorisation (EUA).
India has nearly 4 lakh, COVID-19 patients, now, with nearly 13,000 deaths and fatality rate of 3.28%. On 20th June, 14,516 new cases were reported in India.
"The approval comes at a time when cases in India are spiraling like never before and putting tremendous pressure on our healthcare system. FabiFlu will reduce this pressure. Glenmark will work with the government and medical community to make it quickly accessible to patients across the country," said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals.
The drug acts by getting into cells and inhibit the activity of viral replication to reduce the viral load. A high rate of viral replication can be controlled with the early use of antiviral drugs. In later stages, viral replication slows down and the body's violent immune response drives disease to complications and organ failure, said the company sources.
Glenmark is also undertaking a study combining two anti-viral drugs, Favipiravir (an approved drug for novel flu pandemics) with Umifenovir (an approved drug for Influenza) in COVID-19 patients.
Favipiravir, sold under the brand name Avigan by Fujifilm Toyama Chemical and approved in Japan since 2014 in treating influenza, is already being used commercially in the therapeutic management of COVID-19 in Bangladesh and UAE.
It is under the approval process in Egypt and Jordan and is a part of the treatment protocol in Russia, Japan, and Saudi Arabia. About 18 global clinical trials in 3,000 subjects are going on including in India, the USA, Canada, Italy, China, France, UK, and other countries.
The drug has been approved for compassionate use on 2,050 COVID-19 patients in Japan. It's also approved for novel or re-emerging pandemic influenza virus infection in the country. A 760 patient trial of Favipiravir is also undergoing in Canada. A couple of studies in China had also shown promising results. A Russian study among 390 patients had shown an 80 percent-plus success rate and a trial among 2,141 patients in Japan showed an above 88 percent success rate.
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Putin meets Iran's FM Araghchi, says Russia ready to do its best to help bring peace to West Asia
Moscow (PTI): Iran's Foreign Minister Abbas Araghchi on Monday met Russian President Vladimir Putin, who hailed the Iranian people for fighting bravely and heroically for their sovereignty and said Moscow is ready to do its best to help bring peace to West Asia as soon as possible.
Araghchi, who held talks with Omani and Pakistani leadership before arriving in Russia, met Putin in St. Petersburg and thanked him for supporting Iran, state-owned TASS news agency reported.
"Russia is ready to do everything in its power to ensure that peace in the Middle East is achieved as soon as possible," Putin said during his meeting with Araghchi, which was also attended by Russian Foreign Minister Sergey Lavrov.
Revealing that he received a message from Iranian Supreme Leader Mojtaba Khamenei last week, Putin asked Araghchi to convey his "gratitude for this message and best wishes for his health and well-being."
He praised the Iranian people for fighting "bravely and heroically" for their sovereignty, Iran's state-run PRESS TV reported.
"We really hope that, based on the courage and desire for independence, the Iranian people, under the guidance of the new leader, will weather this difficult period of trials and peace will come,” Putin said.
He also stressed that Russia “intends to maintain” its strategic relations with Iran.
Araghchi said that the world witnessed Iran’s strength in countering the US during the recent war, and that the Islamic Republic is a "stable and powerful establishment."
"With their courage, the Iranian people succeeded in resisting the US aggression and will be able to endure it,” he said.
He said that it became clear that Iran has “great friends and allies” like Russia, and conveyed “warmest greetings” from Supreme Leader Mojtaba Khamenei and President Masoud Pezeshkian to the Russian leader.
Araghchi said relations between Moscow and Tehran represent a “strategic partnership at the highest level” and will continue to develop "regardless of circumstances."
"We are grateful to you for the solid and strong positions in support of the Islamic Republic of Iran," he said.
Foreign Minister Lavrov said that the talks between President Putin and the Iranian Foreign Minister were "useful and constructive."
Kremlin Spokesman Dmitry Peskov later said that Russia is "ready to provide any good offices, any mediation services that are acceptable to the parties."
"We will be ready to do everything so that ultimately peace ensues, guaranteed peace, and that there is no return to hostilities," Peskov was quoted as saying by TASS.
He was asked how Moscow can assist in future negotiations on the Iranian settlement.
Araghchi arrived in Russia after his whirlwind trip to Islamabad, which, according to him, was “very productive” and involved “good consultations" with Pakistan's Army Chief Field Marshal Asim Munir, amid uncertainty over the second round of peace talks to resolve the war in West Asia.
"We held good consultations with our friends in Pakistan. The trip was successful. We assessed the outcome of our recent (meetings) and discussed in what direction and under what conditions talks can move on,” Araghchi said in a video posted on his Telegram channel upon his arrival in St Petersburg.
Referring to the second round of talks between the US and Iran to resolve the conflict in West Asia, Araghchi said: "Developments have taken place in the negotiations."
"Despite some progress in earlier rounds, the talks failed to reach their objectives due to the Americans' approach, the excessive demands they made, and the wrong approaches they adopted. Therefore, it was necessary to consult with our friends in Pakistan to review the latest situation,” Iran's official news agency IRNA quoted him as saying.
He said that the trip to Pakistan was a good opportunity to review developments related to the US-Israeli war against Iran, expressing confidence that “these consultations and coordination between the two countries will be highly significant.”
Araghchi arrived at St. Petersburg's Pulkovo Airport early Monday, where he was welcomed by Russian officials and Iran’s ambassador to Russia, Kazem Jalali, the report said.
The first round of peace talks between Iran and the US, held on April 11 and 12, failed to bring the desired result for the parties to the conflict.
The Iranian minister arrived in Islamabad for the second time on Sunday after a short visit to Oman, where he held talks with Sultan Haitham bin Tariq al-Said on security in the Strait of Hormuz and diplomatic efforts to end the Iran-US conflict.
After Araghchi left Pakistan for Oman on Saturday, President Donald Trump announced that US negotiators Steve Witkoff and Jared Kushner would no longer be going to Islamabad for talks with Iran, contending that Washington held all the cards on the matter.
Trump on Sunday reiterated that the US and Iranian officials can talk by phone for a peace solution to the conflict.
On Tuesday, Trump extended the two-week ceasefire with Iran indefinitely to give Tehran more time to prepare a unified proposal to end the war, just hours before the truce was set to expire.
The war began when the US and Israel jointly attacked Iran on February 28, killing Iranian Supreme Leader Ayatollah Ali Khamenei and several top commanders. The retaliation by the Islamic Republic extended the war to the entire Gulf region.
