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RIYADH: The Saudi Food and Drug Authority has approved the registration of Qalsody (Tofersen) for the treatment of adults with amyotrophic lateral sclerosis linked to mutations in the SOD1 gene, the Saudi Press Agency reported.

ALS is a rare neurodegenerative disease that affects the nerve cells responsible for voluntary movement, gradually causing muscle weakness and leading to loss of mobility over time.

According to the SPA, the approval is part of the SFDA’s efforts to facilitate patient access to treatment, as Qalsody has been designated an orphan drug for the treatment of rare diseases.

Normally, the SOD1 protein helps eliminate toxic byproducts produced during regular cellular activity.

In cases where a genetic mutation in the SOD1 gene causes ALS, a defective protein that fails to protect the cell from toxins is produced. The faulty protein accumulates within the cell, disrupting normal cellular processes.

The SFDA said that Qalsody works to reduce the production of the defective SOD1 protein through a novel therapeutic approach known as antisense therapy. This technique employs small molecules called nucleotides, designed to bind precisely to a specific sequence of mRNA generated by the genetic mutation that causes the protein to misfold. This process limits the cell’s ability to produce the defective protein, reducing its accumulation in the body.

The authority added that the drug’s approval followed a thorough assessment of its efficacy, safety and quality. Clinical studies of patients who received the drug showed a reduction in key indicators of nerve damage, most notably neurofilament light levels, compared with patients who received a placebo. A decrease was also observed in the concentration of the defective SOD1 protein in cerebrospinal fluid, confirming that the drug is acting on its intended molecular target. The authority said, however, that the long-term benefits are still under evaluation and that these early findings are not a substitute for confirmed clinical outcomes.

The SFDA reported that the most commonly observed side effects in clinical studies were muscle and joint pain, fatigue, injection site discomfort, fever and increased levels of certain proteins in the cerebrospinal fluid.

The approval reflects the SFDA’s commitment to expanding access to effective treatments for rare and hard-to-treat diseases through the Orphan Drugs Program, a key strategic initiative designed to accelerate the availability of promising therapies and address unmet medical needs.

It aligns with the goals of the Health Sector Transformation Program, one of the key initiatives of the Kingdom’s Vision 2030, which seeks to improve the quality of healthcare services.

An orphan drug is defined as a medication developed to treat rare diseases that affect fewer than five in 10,000 people in the Kingdom.

The orphan drugs guide is available on the authority’s website at https://www.sfda.gov.sa/ar/regulations/88482. For further inquiries, contact the SFDA via email at [email protected].

KARACHI: Pakistan’s financial inclusion rate has risen to 67% in 2025 from 47% in 2018, the top central bank official said on Thursday, crediting digital innovation and policy reforms for expanding access to financial services.

The rise comes as the government and the State Bank of Pakistan (SBP) have stepped up efforts to strengthen microfinance and digital banking amid a period of relative macroeconomic stability. Officials have also urged the public to use formal banking channels and digital platforms to help build resilience in the financial system.

“Governor Jameel Ahmad highlighted that the financial inclusion rose from 47% in 2018 to 67% in June 2025 while the gender gap in financial access narrowed from 47% to 30% over the same period,” the central bank said in a statement issued after his speech to the ninth Annual Microfinance Conference in Karachi.

“Governor Ahmad assured that the State Bank remains fully committed to working alongside the microfinance industry to strengthen resilience, safeguard customers and expand outreach,” it added.

The top SBP official told the conference that Pakistan’s economic recovery was gathering pace after tough policy measures helped stabilize inflation and foreign exchange reserves. He said inflation had declined sharply and was expected to stay within the government’s 5-7% target range over the medium term.

Ahmed also noted that foreign exchange reserves were now five times higher than in February 2023, reflecting “strategic interbank purchases” that helped the government meet debt repayments without excessive borrowing.

He outlined new principle-based regulations for microfinance banks, allowing greater flexibility and higher lending limits of up to Rs5 million ($17,500) for agriculture, microenterprise and housing loans, and Rs500,000 ($1,750) for general loans.

Ahmad urged microfinance institutions to adopt stronger risk management, enhance liquidity buffers, and use digital tools for credit scoring to prevent fraud and maintain sustainability.

“Together, we can ensure that microfinance continues to play its vital role in fostering inclusive, resilient, and sustainable growth,” he said.