The Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the coronavirus disease (COVID-19) treatment pill developed by pharmaceutical company MSD (also known as Merck).
“Ito po yung Molnupiravir na ang kaniyang brand name ay MOLNARZ. Ito po ay licensee ng MSD (It is the Molnupiravir whose brand name is MOLNARZ. This is an MSD licensee),” said FDA Director-General Rolando Enrique Domingo on Thursday, Dec. 23.
“So far, naka-comply po doon sa ating mga requirements ng (So far, have complied with our requirements for) safety, efficacy and quality,” he added.
Domingo noted that this pill will only be given to individuals who have mild or moderate COVID-19.
“Ito po ay pinapayagan nating ibigay sa mga pasyente with mild to moderate COVID disease so hindi po ito puwede sa mga severe o iyong mga nangangailangan na ng oxygen (We only allow it to be given to patients with mild to moderate COVID, so it is not for those who have severe or those who already need oxygen),” he said.
“Ito ay puwede lamang ibigay sa mga adults 18 years old and above na positive po for COVID-19 and mayroon pong risk factors for developing severe illness katulad po ng mga senior citizen o iyong mga may comorbidities (It can only be given to adults who are 18 years old and above who are positive for COVID-19 and have risk factors for developing severe illness such as senior citizens or those with comorbidities)– who are at risk of going into severe COVID,” he added.
Molnupiravir is given twice a day to patients, said the FDA chief.
“Ito pong Molnupiravir ay binibigay two times a day (This Molnupiravir is given twice a day)--- 800 milligrams two times a day for five days but it should be given as soon as possible after diagnosis at dapat po (and should be) within the first five days after the onset of symptoms,” he noted.
“Otherwise, hindi na po siya masyadong useful at hindi rin po siya puwede sa mga patients with severe illness dahil hindi rin po siya nakakatulong (it will no longer be very useful and it is not suitable for patients with severe illness because this not going to be helpful ),” he added.
Domingo said that Molnupiravir is not recommended for women who are pregnant.
“Hindi po siya puwedeng ibigay sa mga buntis o sa mga maaaring magbuntis dahil hindi gumagamit ng contraception at sa mga lactating women dahil kulang pa po ang datos natin ano para masabi na safe siya para po sa grupo ng pasyenteng ito (This cannot be given to pregnant women, or those who may be pregnant because they do not use contraception, and to lactating women--- because we still lack data to say that it is going to be safe for this group of patients),” he said.