Symdeko* (tezacaftor / ivacaftor) vs Lucaftor (lumacaftor/ivacaftor)

Symdeko (tezacaftor/ivacaftor) and Orkambi (lumacaftor/ivacaftor), which you referred to as Lucaftor, are both combination medications used to treat cystic fibrosis in individuals with specific genetic mutations. Symdeko is generally considered to have fewer side effects and better tolerability compared to Orkambi, which can be important for long-term adherence to the medication regimen. The choice between these medications should be guided by a healthcare provider, who will consider factors such as the patient's specific CFTR mutations, age, overall health, and potential drug interactions, to determine the most appropriate treatment option.

Difference between Symdeko* and Lucaftor

Metric	Symdeko* (tezacaftor / ivacaftor)	Lucaftor (lumacaftor/ivacaftor)
Generic name	Tezacaftor / ivacaftor	Lumacaftor / ivacaftor
Indications	Cystic fibrosis in patients age 6 years and older who have two copies of the F508del mutation or one mutation in the CFTR gene	Cystic fibrosis in patients age 2 years and older who have two copies of the F508del mutation in their CFTR gene
Mechanism of action	Tezacaftor improves the conformational stability of F508del-CFTR, ivacaftor increases the open probability of the CFTR channel	Lumacaftor helps in correcting the folding of F508del-CFTR protein, ivacaftor increases the open probability of the CFTR channel
Brand names	Symdeko	Orkambi
Administrative route	Oral	Oral
Side effects	Headache, nausea, sinus congestion, dizziness, rash, increased liver enzymes	Shortness of breath, upper respiratory tract infection, nausea, diarrhea, rash, fatigue, abnormal chest sound
Contraindications	Use of certain drugs (e.g., strong CYP3A inducers), liver disease	Use of certain drugs (e.g., strong CYP3A inducers), liver disease, history of organ transplantation
Drug class	CFTR modulator	CFTR modulator
Manufacturer	Vertex Pharmaceuticals	Vertex Pharmaceuticals

Efficacy

Efficacy of Symdeko (tezacaftor/ivacaftor) in Cystic Fibrosis

Symdeko, a combination of tezacaftor and ivacaftor, has been approved for the treatment of cystic fibrosis (CF) in patients who have specific mutations in the CFTR gene. Clinical trials have demonstrated that Symdeko can significantly improve lung function as measured by the percent predicted forced expiratory volume in one second (ppFEV1) in individuals with these mutations. The improvement in lung function is associated with a reduction in pulmonary exacerbations, which are acute worsenings of respiratory symptoms that require additional treatment and can lead to a decline in lung function over time.

Furthermore, Symdeko has been shown to improve other aspects of CF, including the overall quality of life and certain respiratory symptoms. Patients taking Symdeko have reported experiencing fewer respiratory symptoms and have demonstrated an increase in their weight, which is an important indicator of improved nutritional status in CF. The therapy is generally well-tolerated, with a safety profile that supports its use in the indicated population.

Efficacy of Orkambi (lumacaftor/ivacaftor) in Cystic Fibrosis

Orkambi, which is a combination of lumacaftor and ivacaftor, is another medication approved for the treatment of CF in patients with the homozygous F508del mutation in the CFTR gene. Clinical studies of Orkambi have shown that it can lead to modest improvements in lung function, as measured by ppFEV1, in individuals with this specific genetic mutation. Similar to Symdeko, Orkambi has been associated with reductions in the rate of pulmonary exacerbations, which is a critical aspect of managing CF and improving patient outcomes.

In addition to its effects on lung function, Orkambi has been reported to improve other CF-related symptoms, including respiratory symptoms and nutritional status, as evidenced by increases in body mass index (BMI) in the patient population. The treatment is generally considered safe for its approved indications, though it is associated with some side effects that need to be managed clinically. It is important to note that the efficacy of Orkambi, like Symdeko, is dependent on the presence of the specific CFTR mutations for which the drug is approved.

Regulatory Agency Approvals

Symdeko*

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA

Lucaftor

ANMAT (ARG)

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