Four FDA approvals PCPs need to know about

Gerald Smetana

NEW ORLEANS — The fact that 2017 was a record-breaking year for FDA approvals did not make it any easier to pick the most important medications for primary care physicians to know about, said a presenter at the American College of Physicians Internal Medicine Meeting.

With so many biologicals approved by the FDA, there were “slim pickings” left for primary care, according to Gerald Smetana, MD, MACP, internist, Beth Israel Deaconess Medical Center in Boston.

Smetana focused his discussion on novel drugs relevant to primary care physicians that were not ‘me too’ agents; specifically, new medications for asthma, allergic rhinitis due to dust mites, gout and shingles:

Mepolizumab ( Nucala , GlaxoSmithKline )

IL-5 inhibitor for patients with severe eosinophilic asthma;
Taken as a 100 mg subcutaneous injection for 4 weeks;
Lowers eosinophil activity and survival;
Decreases airway inflammation;
Lowers corticosteroid requirement;
Has indications that overlap with omalizumab;
Has adverse events that include headache, urinary tract infections, infusion reaction, hypersensitivity; and
Reduces clinically significant exacerbations by 39% to 52% in patient and adolescent trials

Though he gave the drug his ‘thumbs up,’ Smetana explained how availability of the drug could be limited.

“This drug will cost $32,000 a year, which is about twice the cost of the PCSK9 inhibitors for cholesterol,” he said. “I think it’s fair to say that this will be the most expensive drug that most of us will use in primary care and that there will be issues surrounding prior authorization of mepolizumab.”

Odactra (House Dust Mite Tablet, Merck)

Freeze-dried sublingual tablet taken for allergic rhinitis due to dust mites;
Requires first dose to be taken in a doctor’s office due to “rare” chance of anaphylaxis;
Recommended that patients also have ready access to an EpiPen;
Cannot be used in patients already taking tricyclic antidepressants, levothyroxine, diphenhydramine, alpha or beta blockers;
Taken once daily, patients cannot swallow for 1 minute after taking the agent and cannot drink or eat for 5 minutes;
Has benefits that persist for a minimum of 7 years if taken for 4 years; and
Costs $291 a month

Generally allergic rhinitis due to dust mites is treated by primary physicians with nasal sprays and oral medications, but there are reasons to consider switching to sublingual immunotherapy, Smetana said.

“[Candidates would be] those with symptoms that correlate with exposure by history, have a positive skin test or serum allergen specific IgE, those where environmental controls have been maxed out and are still having lifestyle limiting symptoms,” he said.

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Lesinurad (Zurampic, Astra Zeneca)

Single oral dose of 200 mg/day for patients with gout;
Achieved uric acid levels of 6 mg/dL or less in about half of patients;
Is not to be used in patients with eGFR of 40 mL/min/1.73 m² or less;
Patients taking it should have their renal function monitored;
Mild to moderate increase in creatinine common; and
Should not be used as monotherapy without allopurinol

Smetana explained to attendees what makes this particular medication novel.

“It is a selective inhibitor of uric acid transport 1 and organic anion transporter 4, and it also inhibits reabsorption of uric acid in proximal renal tubule and causes uricosuria and reduces serum uric acid levels.”

Shingrix (Recombinant zoster vaccine, GlaxoSmithKline)

Protects against shingles for a minimum of 4 years;
Has immunogenicity that persists for a minimum of 9 years;
Involves two doses, 2 to 6 months apart;
Can be coadministered with influenza vaccine;
Tests performed in 15,411 patients aged 50 and older in 18 countries with no prior zoster vaccine or live virus zoster vaccine; and
Costs $280 for the two doses

Smetana called Shingrix a significant advance, but cautioned that the adverse event profile must be considered.

“Most of them were minor but were a nuisance. An adverse event occurred in the first week of being administered the vaccine at a rate of about 84%. Injection site pain and redness also occurred in many patients, and there were also systemic reactions, such as myalgia, fatigue and fever. Grade 3 adverse events occurred in about a fifth of patients,” he said.

More information about each of these medications can be found by visiting the ‘New Drugs at FDA’ website. Smetana added. – by Janel Miller

Reference:

Smetana G. New medications for primary care: an update. Presented at: American College of Physicians Internal Medicine Meeting; April 17-21, 2018; New Orleans.

Disclosure: Smetana reports no relevant financial disclosures.