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The wait is over as US approves first drug in 20 years for river blindness

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Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. The FDA has also awarded MDGH a priority review voucher (PRV).

River blindness is caused by a parasitic worm, Onchocerca volvulus. The disease manifests as severe itching, disfiguring skin conditions and visual impairment, including permanent blindness, caused by the worm’s larvae (microfilariae).

The approval of moxidectin was based on data from two randomized, double-blind, active-controlled clinical studies.

Each study met its respective primary endpoints, showing a statistically significant superiority of moxidectin over the current standard of care, ivermectin, in suppressing the presence of the microfilariae in the skin.

Full results from the Phase III study were published in the Lancet in January 2018 and a safety summary is provided below.

“FDA approval is a momentous achievement for any biopharmaceutical company, but it is a particularly rare and exciting event in the neglected diseases setting,” said Mark Sullivan, Founder and Managing Director of MDGH.

“It takes a broad community to develop a new medicine. FDA approval represents decades of work by thousands of scientists, disease control specialists, expert advisors, community health workers, funders and study participants. We particularly acknowledge the US$13 million investment from the Global Health Investment Fund (GHIF) as well as the extraordinary persistence and dedication of the team at TDR, without whom this would not have happened.”

TDR (the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases) was instrumental in the development of moxidectin. “We are delighted about the FDA’s decision,” says TDR Director John Reeder. “It is a milestone toward the river blindness endgame and our objective to enable African countries to integrate moxidectin into their elimination strategies.”

This approval is the result of a paradigm-changing approach to the development of new medicines for neglected diseases, enabled by the PRV program. “As neglected tropical diseases are endemic in low and middle-income countries, there are limited markets for medicines. Therefore, finding investors willing to support development in these diseases is extremely difficult,” added Mark Sullivan. “However, the introduction of the FDA’s neglected diseases PRV program has created a market around neglected diseases.”

The PRV legislation was designed to encourage the development of new drug and biological products for neglected diseases. The PRV, a saleable item, permits the holder to accelerate the review of a new drug application (NDA) from the standard 10 months to 6 months. This time saving has significant value to the pharmaceutical industry, thus creating an indirect market for neglected disease treatments.

Dr. Reeder added, “This voucher to MDGH exemplifies the original spirit of the programme – to create incentives for research and development in neglected diseases.”

MDGH is the first not‑for‑profit company to register a medicine through the tropical disease PRV program. “This is exactly what we had in mind when we proposed the PRV program,” said Duke University’s Professor David Ridley, an author of the 2006 paper on which the voucher scheme is based.

“The voucher incentive helped Medicines Development for Global Health attract funding to complete testing and registration for a drug that had been on the shelf. I’m delighted that the voucher program is playing a role in treating patients with river blindness, and one day eliminating the disease.”

“Achieving FDA approval is a critically important milestone for moxidectin, but our work to bring this medicine to those who need it most continues in earnest,” concluded Mr. Sullivan. “MDGH plans to provide the community with additional data, including data in younger children. We are here for the full journey – we have committed our skills and resources to play our part in ridding the world of this disabling disease.”

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River Blindness

River blindness is caused by the parasitic worm Onchocerca volvulus, which is transmitted from person to person by black flies that breed in fast-flowing rivers in sub-Saharan Africa, Yemen and small foci in South and Central America.

The association of rivers and streams, together with the worst manifestation of O. volvulus infection, blindness, led to the adoption of the more commonly known term for the disease, “river blindness”.

The millions of larvae (microfilariae) released by the infecting adult parasites invade skin and eyes where they can cause severe manifestations, including permanent blindness, itching and disfiguring skin conditions.

Nearly 200 million people are at risk for river blindness, and more than 99% of people infected live in sub-Saharan Africa. Chemotherapy with ivermectin, previously the only drug currently approved by the FDA for onchocerciasis, is the current standard approach to onchocerciasis control and elimination.

Ivermectin has significantly reduced the disease burden, but new treatment options are needed to accelerate progress toward eliminating parasite transmission.

Moxidectin

Moxidectin is a macrocyclic lactone anthelmintic medicine that selectively binds to the parasite’s glutamate-gated chloride ion channels.

These channels are vital to the function of invertebrate nerve and muscle cells. Moxidectin has activity against O. volvulus microfilariae but does not kill adult O. volvulus parasites.

Patients with river blindness administered moxidectin experienced adverse events consistent with those associated with efficacy.

The nature and severity of adverse events in moxidectin recipients were similar to ivermectin. The most common adverse reactions (incidence > 10%) were: eosinophilia, pruritus, musculoskeletal pain, headache, lymphopenia, tachycardia, rash, abdominal pain, hypotension, pyrexia, leukocytosis, influenza-like illness, neutropenia, cough, lymph node pain, dizziness, diarrhea, hyponatremia and peripheral swelling.

The efficacy of repeat administrations of moxidectin has not been assessed. Moxidectin is supplied as 2 mg tablets for administration as an 8 mg dose per oral to patients at least 12 years of age with O. volvulus infection.

Source: CNBC

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First Lady Oluremi Tinubu Flags off Free to Shine Campaign Against HIV/AIDS, other STDs in Enugu

Gov. Mbah, wife, pledge collaboration, reports SANDRA ANI

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Senator Oluremi Tinubu

Nigeria’s First Lady, Senator Oluremi Tinubu, has flagged off the Free to Shine Triple Elimination Campaign, an initiative of the Organisation of African First Ladies for Development, OAFLAD, and global partners to eradicate HIV/AID, Syphilis and Hepatitis by 2030.

Flagging-off the campaign at the International Conference Centre, Enugu, on Tuesday, the founder of the Renewed Hope Foundation, Senator Tinubu said the initiative was an imperative, since Nigeria bore the highest burdens of HIV infection in sub Saharan African due to her large population.

“We launched the campaign in January 2025 and have flagged it off in five political zones of North Central, North East, North West, South South and South West. Today, we have flagged off the campaign in southeast to complete the Free to Shine campaign.

“Our aim is to reduce HIV infection among women, prevent mother and child transmission and ensure that every child born with it gets the necessary treatment,” Tinubu said.

First lady Senator Oluremi Tinubu, Governor Peter Mbah and wife
First lady Senator Oluremi Tinubu in a group photograph with Governor Peter Mbah, the wife and other dignitaries at the event.

She thanked Governor Peter Mbah of Enugu State and his Wife, Mrs. Nkechinyere Mbah and the people Enugu State for the warm reception accorded to her and her entourage. During her two-day working visit.

Throwing his weight behind the campaign, Governor Mbah, said his administration had taken health seriously because a healthy population is the foundation on which progress is built.

“Here in Enugu State, we have aligned our healthcare priorities with the vision of the ‘Free to Shine Campaign.’

“By September, we would have completed and fully equipped 260 Type 2 Primary Healthcare Centres in all wards — each with accommodation for health workers to ensure round-the-clock care.

“We have also strengthened our secondary and tertiary healthcare systems and broadened access to health insurance and emergency services, especially for the most vulnerable.

“These efforts are already yielding results — with a significant reduction in maternal, under-five and infant mortality.

“But we know the work is not done. No health system can thrive in isolation or assume it no longer needs support. This is why we embrace the goals of the ‘Free to Shine Campaign’ — goals that seek to eliminate stigma, expand access to HIV treatment, and, most importantly, end mother-to-child transmission of HIV,” he stated.

The First Lady of Enugu State, Mrs Mbah, commended Senator Tinubu and OAFLAD for providing leadership against the scourges of HIV/AIDS and other sexually transmitted diseases.

“I commend the First Lady, Her Excellency Senator Oluremi Tinubu, for demonstrating leadership and commitment to the health and well-being of Nigerians.

“As 2023 data from the Joint United Nations Programme on HIV/AIDS (UNAIDS) shows, Nigeria has one hundred and forty thousand (140,000) children aged 0 – 14 living with HIV, with twenty-two thousand (22,000) deaths each year. This is an enormous public health burden with vast social and economic implications. So, the ‘Free to Shine Campaign’ is indeed a creation of necessity,” Mrs. Mbah said.

She expressed total support for the initiative, noting that “collaboration is the driving force of change and development.”

“When we collaborate, problems that seem intractable are solved. So, I am confident that the goals of this campaign will be achieved in Enugu State, in Nigeria – and across Africa. What is required is whole-hearted dedication,” she concluded.

The event featured a general overview of the Free to Shine Campaign, by the Executive Secretary for OAFLAD, Dr. Nardos Berhanu, testimonials and experience sharing by persons living with HIV/AIDS, drama presentation by Members of the National Youth Service Corps, and goodwill messages by development partners, among others.

Meanwhile, the Nigerian First Lady was conferred with the chieftaincy title of Ugosinamba (Precious Jewel/Eagle from another kingdom) by the Enugu State Council of Traditional Rulers, citing her love for Enugu and service to the nation and humanity.

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Enhancement of Military Health Services: Matawalle Meets U.S. Deputy Assistant Secretary of Defence for Health

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Dr. Bello Muhammed Matawalle
Minister of State for Defence, H.E. Dr. Muhammad Bello Matawalle

In a significant move to bolster Defence Health Services and strengthen the partnership between the United States and Nigeria, the Minister of State for Defence, H.E. Dr. Muhammad Bello Matawalle, met with a U.S. delegation led by Dr. David Smith, Deputy Assistant Secretary of Defence for Health.

A statement endorsed by Henshaw Ogubike, director of Information and PR at the Ministry, shows that the the meeting focused on enhancing the existing collaboration in defence health between the two nations, which has previously facilitated the establishment of high-tech laboratories in Nigeria.

The Honourable Minister commended the U.S. for their efforts and urged for the expansion of these medical facilities beyond Abuja and Lagos to reach more derserved regions.

Dr. Matawalle emphasized the strategic integration of health services to improve the welfare of the Armed Forces of Nigeria, stating, “A healthy military is the backbone of a strong nation.” He reiterated the government’s commitment to ensuring that military personnel have access to top-tier healthcare services and facilities. To this end, he called for an increase in the defence budget allocated to health, viewing it as a vital investment in the nation’s future and stability.

Furthermore, the Minister highlighted that these initiatives align with Nigeria’s broader commitment to enhancing military readiness while addressing public health challenges that affect both service members and the civilian population. He noted that President Bola Ahmed Tinubu’s administration is dedicated to improving healthcare for military personnel and civilians, recognizing healthcare as a cornerstone of national security.

In his remarks, the Permanent Secretary of the Ministry of Defence, Dr. Ibrahim Abubakar Kana mni, stated that this initiative would positively impact military health and serve as a model for strengthening Nigeria’s overall healthcare system. “This collaboration marks a turning point for Nigeria’s defence health system,” he asserted.

Dr. Smith praised the Minister for his proactive approach to health readiness, underscoring the critical connection between health systems and military effectiveness. “Health is as crucial as any weapon system in ensuring military success, and we are committed to supporting Nigeria’s efforts to enhance its defence health system,” he remarked.

The U.S. delegation is in Nigeria to further advance initiatives aimed at sustaining progress against HIV, accelerating efforts towards the United Nations’ 95-95-95 goals, and working towards the elimination of HIV as a public health threat by 2030.

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Neptune Prime publisher to unveil cancer clinic, school, foundation for late journalists’ families as son weds in Yobe

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publisher of Neptune Prime newspapers, Dr Hassan Gimba
Publisher of Neptune Prime newspapers, Dr Hassan Gimba

The publisher of Neptune Prime newspapers, Dr Hassan Gimba, has announced plans to commission three major projects in his home state, Yobe State

In an invitation letter sent to newsmen on Wednesday, the publisher disclosed that the event, which is scheduled to take place on August 31, is coinciding with the wedding Fatiha of his son, Barrister Suleiman Gimba.

According to the letter, the wedding Fatiha will take place by 11:00am at the residence of Mohammed Babate, Behind Water Board, Army Barracks, Potiskum.

“Immediately after the wedding Fatihah, we will be commissioning the Hafsatu Gimba Ahmed Memorial School located at VIO Street, Unguwar Jaji, Potiskum.

“This institution is dedicated to the memory of my late mother, aiming to serve the educational needs of our community,” the letter noted.

Dr Gimba added that as part of the launch programme, the Abubakar Monja Lifeline Foundation for Late Journalists’ Families, which he founded to cater to the families of journalists who have passed away, will be empowering youths it trained in tailoring and plumbing.

“Additionally, I would like to invite you to inspect the ongoing construction of the Lami Fatima Babare Cancer Outreach and Clinic situated nearby, also in Unguwar Jaji.

“The clinic is an initiative of the Lami Fatima Babare Cervical Cancer Foundation, which was founded in 2020 – in memory of my late wife, Lami Fatima Babare – to provide medical services and referrals to cancer patients,” the letter noted.

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