Health

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

Published

7 years ago

June 15, 2018

grassroots

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

Health

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

Published

2 days ago

December 20, 2024

grassroots

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.

Health

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

Published

4 months ago

August 29, 2024

grassroots

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.

Health

Enugu State Gov’t Moves to Revamp Oji River College of Health Technology,

…beefs up security

Published

4 months ago

August 25, 2024

grassroots

The Enugu State Government has announced its intention to revamp the existing infrastructural facilities to give the Enugu State College of Health Technology in Oji River a face-lift and also scale-up institution to a technology-savvy citadel of learning.

The government made this known during a meeting with the management, staff, and students of the institution at the Enugu State Government House at the weekend, stressing its commitment to ensuring quality health service delivery in the state.

The government, which made this known through the Special Adviser on Health Matters, Dr. Yomi Jaye, also asked the students of the institution to go back to school and continue with their academic calendar, as all those involved in the recent breach of security in the school’s neighborhood had been rounded up and now facing the law.

The governor equally gave the college management a two-week ultimatum to develop a workplan, which the government would work on to ensure that the school functions at its optimum level.

Briefing Government House correspondents after the meeting, Dr. Jaye said, “We interacted with the management, staff and students of the Enugu State College of Health Technology, Orji River, to come up with a strategic plan to revamp the college and restore its lost glory.

His Excellency, Governor Peter Mbah, has expressed his willingness not only to revamp the school, but to upscale it to a technology-savvy teaching community.

“As you can see, the government is bullish about building Type-2 Healthcare Centre in each of the 260 wards and this college will produce some of the qualified workers that will deliver quality healthcare services to Ndi Enugu.

“We appeal to the parents and guardians to allow the students to go back to school and resume their academic activities as more security personnel have been deployed to make sure that both Oji River and its neighbouring communities are properly secured.

“It is also important to inform you that those who perpetrated the security breach have since been arrested and the victims, which included one student, also freed,” he maintained.

Also speaking, the Provost of the College, Dr. Lazarus Ezugwu, expressed his happiness over the state government’s move to revamp the institution, saying he was optimistic that the glory of the institution would be restored in no distant time.

When commending Governor Peter Mbah and the security agencies for their swift response to the recent security breach at the College, he also confirmed that security had been strengthened around the institution and Oji River in general.

“The meeting is such a commendable one. It goes a long way in telling us the type of visionary leader we have in the state. To be sincere, the total overhaul that will be done in the college is going to be enormous. What is coming to the college cannot be imagined because the governor has shown both special interest and political will. This is what we have been yearning for, for so many years,” Dr. Ezugwu stated.